of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.
Become a maker of possible with us. The Senior Supplier Quality Engineer is responsible to define and implement the supplier management activities required to approve suppliers and maintain their approved status throughout the product lifecycle. This is achieved by ensuring the conformance of the supplier to applicable quality specifications
of components, products, materials, or services delivered to BD, in compliance with BD supplier management policies and procedures, as well as applicable standards and regulations.
Responsibilities Support identification of prospective suppliers. Define the optimum supplier approval strategy, and create supplier approval plans. Facilitate, manage, and track supplier progress toward Approved status, supporting both new product development launches and sustaining engineering changes. Conduct supplier quality audits backssments as necessary including for-cause audits, and complete follow-up and closure of any non-conformances. Author, negotiate, and finalize both Quality and Technical Agreements
with suppliers. Review and approve supplier FMEAs, SPC strategies, MSA documentation, control plans and inspection methods as required by the Supplier Approval Plan.
Provide Supplier Quality Assurance support to all existing suppliers and assigned projects (including suppliers for new product development). Collect and archive all relevant Supplier documentation and required statements. Support Supplier Quality performance monitoring. Create Supplier Quality Roadmap. Manage changes initiated by suppliers while coordinating with the appropriate project teams. Lead problem solving activities with assigned Suppliers related to escalated customer complaints or manufacturing deviations.
Knowledge and Skills : Auditing experience. Understanding of industry standards and regulations such as ISO 9001, ISO 13485, 21CFR820, ISO 14971, MDSAP, EU MDD/MDR. Excellent written and oral communication skills. Working knowledge of problem-solving techniques such as PDCA, 8D investigation, etc. Ability to handle multiple tasks/projects simultaneously with limited supervision. Ability to work with diverse, multi-national, cross-functional teams. Working knowledge of statistics. Minimum Requirement: BS degree in Engineering, Science, or other related discipline At least 5 years of medical device, biologic, medical, or diagnostic industry experience (or equivalent).
Minimum 3 years in a quality organization dealing with suppliers, customers or Operation-Quality. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We encourage people with the creativity and aim to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift NA (United States of America) Apply Save Job Responsibilities Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world.
Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve.
Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. The Senior Supplier Quality Engineer is responsible to define and implement the supplier management activities required to approve suppliers and maintain their approved status throughout the product lifecycle. This is achieved by ensuring the conformance of the supplier to applicable quality specifications of components, products, materials, or services delivered to BD, in compliance with BD supplier management policies and procedures, as well as applicable standards and regulations.
Responsibilities Support identification of prospective suppliers. Define the optimum supplier approval strategy, and create supplier approval plans. Facilitate, manage, and track supplier progress toward Approved status, supporting both new product development launches and sustaining engineering changes. Conduct supplier quality audits backssments as necessary including for-cause audits, and complete follow-up and closure of any non-conformances. Author, negotiate, and finalize both Quality and Technical Agreements with suppliers.
Review and approve supplier FMEAs, SPC strategies, MSA documentation, control plans and inspection methods as required by the Supplier Approval Plan. Provide Supplier Quality Assurance support to all existing suppliers and assigned projects (including suppliers for new product development). Collect and archive all relevant Supplier documentation and required statements. Support Supplier Quality performance monitoring. Create Supplier Quality Roadmap. Manage changes initiated by suppliers while coordinating with the appropriate project teams. Lead problem solving activities with assigned Suppliers related to escalated customer complaints or manufacturing deviations.
Knowledge and Skills : Auditing experience. Understanding of industry standards and regulations such as ISO 9001, ISO 13485, 21CFR820, ISO 14971, MDSAP, EU MDD/MDR. Excellent written and oral communication skills. Working knowledge of problem-solving techniques such as PDCA, 8D investigation, etc. Ability to handle multiple tasks/projects simultaneously with limited supervision. Ability to work with diverse, multi-national, cross-functional teams. Working knowledge of statistics. Minimum Requirement: BS degree in Engineering, Science, or other related discipline At least 5 years of medical device, biologic, medical, or diagnostic industry experience (or equivalent).
Minimum 3 years in a quality organization dealing with suppliers, customers or Operation-Quality. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We encourage people with the creativity and aim to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive.
And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift NA (United States of America) Apply Save Job PDN-9ae7db20-2dba-4c1c-b8ba-a18d92fecad3
kick off meeting, as well as weekly project meeting. Participate in to tech transfer activity. Represent quality department during client meetings. Work with trifunctional department to ensure project related activity is completed on time. This role supports internal and external audits which may include interaction with Health Authorities and clients.
Essential Functions and Responsibilities Below is the summary of the role responsibilities. This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves
the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Attends project kick-off meetings to understand the scope of the project.
Creates, updates, reviews and/or approves project related documents such SOPs, Batch release templates, label templates, batch records, change controls, etc. according to client requirements and project scope. Participates in tech transfer activity to ensure adherence to company quality system standards. Proactively identifies risk and prepares mitigation strategies associated with project and client work. Represents QA Client Services during scheduled meetings with client and cross functional
department. Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule.
Participates in client meetings and monitor quality activities of internal team members as they relate to contract deliverables. Draft initial Quality agreement and complete necessary revisions based on client and company requirements. Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate. Provides quality data to Project Manager for the purpose of creating KPI metrics. Builds rapport with clients and troubleshoots issues of concern with internal team in order to provide the highest quality services which meet the needs and requirements of our clients.
Updates and maintains accurate information for each client on project-related documentation repository (i. e. Share Point). Communicates internally within QA team to provide key updates on project status, timelines, and deliverables. Formulates and prioritizes appropriate responses to client requests or concerns. Trains Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline. Supports, participates and follows up appropriately to internal, regulatory agency and client audit requests on a timely basis.
Identifies and supports continuous improvement opportunities working cross departmentally or cross functionally n order to enhance operations. Other duties may be assigned Qualifications Bachelor's Degree in Life Sciences Minimum 5 years experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred. Experience in authoring, reviewing, and /or approving c GMP/c GTP related documents (Investigation report, CAPA report, SOPs etc. ) required.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc. Familiar with FDA, ISO, and other regulatory agency guidelines. Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required. Working knowledge and technical understanding of aseptic manufacture of biologics preferred. Experience in both clinical and commercial manufacturing is preferred. Experience participating health authority inspections and/or client audits preferred. Experience in organizing teams for effective and timely completion of projects.
Competencies/Candidate Profile Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect. Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.
Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
Composure: Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress; is not knocked off balance by the unexpected; doesnt show frustration when resisted or blocked; is a settling influence in a crisis. Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.
Requires 2 years of experience in all of the following: 1) Working in the software development industry and participating in a te Jam environment; 2) Automation tools such as Selenium Web Driver; 3) Automation testing using Selenium and/or Web Driver with C#; 4) Java or similar; 5) Relational databases like SQL Server or Postgres.
Requires 1 year of experience in all of the following: 6) Testing web services such as RESTful APIs; 7) Testing using tools such as JMeter; 8) Continuous Integration tools like Bamboo; and 9) AWS services like S3, Lambda. 40 hours/week, $77,813 - $104,000 per year. Must also have authority to work permanently in the U. S. Applicants who are interested in this position may
commercial in-process and final product labels for labeling operations. Responsible for ensuring accurate printed information on labels in compliance with health authority requirements. Coordinates with production teams to ensure timely issuance of labels.
Performs training of label control and issuance requirements for internal personnel as needed. Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required. Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned. Provides support during internal
and health authority inspections and audits of facility. Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
Performs supplemental investigations/projects as required by Management. Maintains knowledge of current GMPs and regulatory guidelines. Must Have: Minimum of 1 year of relevant labeling experience in a c GMP/FDA regulated environment preferred Some document management experience. Crystal reports and Bar Tender experience preferred. Experience Basic Qualifications: Minimum of 1 year of relevant labeling experience in a c GMP/FDA regulated environment. Some document management
experience. Crystal reports and Bar Tender experience preferred.
Strong communication and customer service skills. Strong computer skills with MS Office (e. g. Word, Adobe, Visio and Excel) and with Quality Systems (e. g. Document Management System, Quality Management System). Develop and improve label issuance processes to drive operational efficiency. Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement. Able to prioritize, manage time well, multi-task, and troubleshoot effectively. Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
Possess project management skills. Experience interacting with FDA or other regulatory agencies strongly preferred. Strong knowledge of c GMPs and domestic regulatory requirements. Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc. ). Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network. Education: Bachelor's degree or Associate's Degree with 3+ Years of Experience in a c GMP/FDA Regulated Environment Vinay Bhatiya Associate- Recruitment PAY RANGE AND BENEFITS: Pay Range: $33.00 - $36.00 per hour Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & shop coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) Clearly Rated Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website : / Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, interaction, age, physical or mental disability, veteran status, marital status, domestic partner status, interactionual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.
If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-xyz X. Please indicate the specifics of the assistance needed.
Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (Hire Genics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U. S. C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. Thanks, American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.
PDN-9ae3d1a9-7e1d-40ff-a10b-ad8ffa312d87
of design quality plans and procedures for design-build projects of a similar size and scope. This position is 100% on site (EWR Airport in Newark)With us, you get work-life balance with engaging on-site roles and ample time off, opportunities to advance your skillset, and of course, full benefits.
With our medical, dental & vision benefits, along with 401k contribution matching, we're as dedicated to helping you develop as we are in developing our next project. When you work for JGM, you're joining a dynamic group of people working on a diverse portfolio of projects from construction and project management, to engineering, to architecture. We believe in diversity, closing the gender
gap, and compliance (aka employee rights, safety and support). DUTIES Managing the scope, schedule, budget, safety, and quality of multiple rail transit construction and design-build projects from commencement to completion.
Coordinating and scheduling engineering and inspection services, maintaining client and subcontractor relationships, and generating and maintaining project status reports. Reviewing and commenting on design documents, including performing constructability reviews; reviewing and approving reports and construction-phase documentation to ensure compliance with project specifications, drawings, building codes, and all other related regulations and applicable industry
standards. Overseeing and managing a project team. Interfacing with owner management teams and labor resources, and acting as owners representative in all forums.
Reviewing schedules and estimates for accuracy. Participating in change order negotiations (including assisting in the creation of scopes of work and independent estimates); Coordinating and executing contractor access and protection requests including track outages / GOs, foul time, property access requests, flag protection, and force-account labor (i. e. track, signal, power, and other owner-employed disciplinary labor groups); Chair meetings and lead project presentations as owners-representatives.
Reviewing and commenting on all meeting minutes. Review proposals, invoices, requisitions, and purchase orders for processing. As well as all other related duties as assigned. QUALIFICATIONS Must have a minimum of 10 years of relevant management and project leadership experience managing projects and associated staff; any other suitable combination of education, training, or experience is acceptable. Bachelor's Degree in Engineering, Construction Management, Architecture, or Business Management is required. A Valid PE or RA License is required. CCM Certification is highly preferred. Must have experience with, executing design-build and/or construction projects within an operating rail transit system, including general knowledge of rail transit operations; Must have an understanding of the fundamentals of rail industry codes, standards, and requirements, with the ability to comprehend construction plans and documents; Must have excellent oral and written communication skills; with outstanding interpersonal skills; Must be detail-oriented, with the ability to multi-task in a fast-paced environment; Must be willing to work nights and weekends as needed.
May also require a valid, clean driver's license and personal vehicle to travel to the project site.
Experience in Port Authority of NY and NJ (PANYNJ) Projects. Minimum 10 years of relevant work experience Proactive self-starter with a proven ability to work independently and efficiently. Must be able to pass PANYNJ background & and badging. Must be able to commute to EWR Airport. Visit our website at We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, interaction, interactionual orientation, gender identity, national origin, veteran or disability status. PDN-9ae3d1ad-66f6-4e34-bd41-265e96452bb6
to stop work. The CQCM shall have demonstrated experience in construction with at least 10 years of experience in quality control activities, including preparation and implementation of quality plans and procedures for design-build projects of a similar size and scope.
This position is 100% on site (EWR Airport in Newark)With us, you get work-life balance with engaging on-site roles and ample time off, opportunities to advance your skillset, and of course, full benefits. With our medical, dental & vision benefits, along with 401k contribution matching, we're as dedicated to helping you develop as we are in developing our next project. When you work for JGM, you're joining a dynamic group
of people working on a diverse portfolio of projects from construction and project management, to engineering, to architecture. We believe in diversity, closing the gender gap, and compliance (aka employee rights, safety and support).
Duties: Develop and implement project-specific quality control. Inspect and evaluate the work area by plans, specifications, and contract documents, reporting deficiencies as appropriate and elevating issues as needed to ensure safe work practices and quality Develop, gather, maintain, and/or submit work plans, submittals, reports, etc. Ensure that subcontractors are aware of all project quality control. Plan for and conduct a three-phase inspection program
to include: Preparatory Meetings and Reports; Initial Phase Inspections and Reports; Follow-up Inspections and Reports; and Final Phase Inspections and Lead and document quality control meetings with the project team and/or customers, and provide written minutes.
Provide daily quality control reports to achieve desired quality outcomes promptly by reinforcing activities that are being constructed in conformance with project-specific standards, and constructively confront non-conformance Verify and document that all materials/equipment received for the project are in conformance with the approved submittal, are handled and stored appropriately, and are acceptable for use in the project; check for damaged and defective materials and address Schedule, coordinate, and document all required code and independent inspections.
Clearly document, correct, and re-inspect all non-conformances before covering up work. Review the as-built drawings to ensure that they are current and that deviations from the contract drawings are Review the Job Site Safety Plan, verify that a hazard analysis has been approved before the performance of a specific feature of work during the preparatory phase of control, verify that safety measures are in place during the initial phase of control, and conduct safety inspections during the follow-up phase of control.
Stop work; reject materials and/or equipment; and direct the removal and replacement of any work not in compliance with contract documents, applicable codes, building standards, and/or established principles of construction engineering, or activities that present life-threatening conditions or damage to the site. Communicate and interact as a team member with all trades, manufacturers, suppliers, construction staff, and customer representatives, in a professional Minimum Requirements: Bachelor's degree in construction management, construction science, engineering, or related field from an accredited university preferred.
Minimum of 10 years experience in programs of similar size and scope. Current OSHA 30; First Aid/CPR; and Construction Quality Control Management certifications; or ability to obtain within 30 days of hire Exceptional communication skills (written and verbal); and ability to interact professionally with customers, coworkers, and subcontractors. Exceptional organizational and time management skills Proficient with Microsoft Office (Outlook, Excel, Word, Power Point, etc. ) and Procore.
Experience in performing, monitoring, and reviewing planning and scheduling functions, which include schedule development, control, and analysis, in the field and the home office. Skilled in oral and written communication. Advanced level of knowledge of engineering, procurement, contracts, construction, and startup work processes, as performed by Bechtel. Knowledge of engineering and construction management customarily acquired over time through specialized instruction or practical experience. Demonstrated ability to plan, organize, direct, perform, review, and present scheduled products independently with minimal supervision.
This includes using a high level of professional judgment and knowledge related to technical planning and scheduling skills and engineering design, construction, and procurement practices. Experience on major lump sum projects with a direct-hire construction strategy is preferred. Experience in Port Authority of NY and NJ (PANYNJ) Projects. Minimum 10 years of relevant work experience Proactive self-starter with a proven ability to work independently and efficiently. Must be able to pass PANYNJ background & and badging. Must be able to commute to EWR Airport.
Visit our website at We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, interaction, interactionual orientation, gender identity, national origin, veteran or disability status. PDN-9ae3d1ad-460b-4586-8bda-02cbeb6a7b69
to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.
The position requires the ability to handle multiple projects, from product inception through product launch and maintenance.
In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world.
Advancing the world of health is our Purpose, and it's no small feat. It takes the creativity and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find entrepreneurial solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Main Responsibilities: Evaluation of customer requirements to identify applicable quality standards Serve as core team member
Release product during development activities Realization of quality functional reviews Ensure implementation of PS global procedures and standards for QE engineering activities Provide support to internal, regulatory body and customer audits and associated corrective actions.
Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products Consistent application of technical principles, theories, concepts and quality sciences / tools Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc. Contributes to the completion of specific programs and projects Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers Independently determines and develops approach to solution May provide guidance and work direction to other team members Designs and performs development working independently within defined parameters with minimal supervision required Liaise with Manufacturing Plants Provide functional support to cross-functional teams Define product control strategy Lead risk management activities Ensure design control elements are satisfied Ensure/ perform process validation activities Develop/ perform supplier qualification plans have been defined and completed Evaluate test methods used in project activities Develop systems, processes, and procedures related to project quality activities.
Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share Ensuring the terms on the agreement are met Support customer facing teams by providing technical support from a quality perspective. Share risk mitigation strategies and control plans for the device with the customers as applicable.
Position Requirements: Education: BS degree in Engineering, or other scientific field Experience: Quality Engineering experience or 12+ years industry experience (Medical Device/ medical) Special Skills: Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMPKnowledge of design control principles. Thorough understanding of statistical methods for Quality Assurance Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management. Knowledge and experience in manufacturing, project management and engineering. Good written and oral communication skillinteractioncellent problem solving and analytical skills Must possess excellent oral and written communication skills, and supervisory/leadership capability.
Ability to handle multiple projects simultaneously in an unsupervised environment. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We encourage people with the creativity and aim to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive.
And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift Apply Save Job Responsibilities Job Description Summary Reporting to the Senior Manager, Quality Engineering for the Franklin Lakes design center, the Staff Quality Engineer II for the Wearable Injector platform will serve as a core team member, and is responsible for combining design control expertise, creative problem-solving approaches and strong analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.
The position requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat.
It takes the creativity and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year-to look at the impossible and find entrepreneurial solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Main Responsibilities: Evaluation of customer requirements to identify applicable quality standards Serve as core team member Release product during development activities Realization of quality functional reviews Ensure implementation of PS global procedures and standards for QE engineering activities Provide support to internal, regulatory body and customer audits and associated corrective actions.
Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products Consistent application of technical principles, theories, concepts and quality sciences / tools Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
Contributes to the completion of specific programs and projects Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers Independently determines and develops approach to solution May provide guidance and work direction to other team members Designs and performs development working independently within defined parameters with minimal supervision required Liaise with Manufacturing Plants Provide functional support to cross-functional teams Define product control strategy Lead risk management activities Ensure design control elements are satisfied Ensure/ perform process validation activities Develop/ perform supplier qualification plans have been defined and completed Evaluate test methods used in project activities Develop systems, processes, and procedures related to project quality activities.
Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share Ensuring the terms on the agreement are met Support customer facing teams by providing technical support from a quality perspective.
Share risk mitigation strategies and control plans for the device with the customers as applicable. Position Requirements: Education: BS degree in Engineering, or other scientific field Experience: Quality Engineering experience or 12+ years industry experience (Medical Device/ medical) Special Skills: Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMPKnowledge of design control principles. Thorough understanding of statistical methods for Quality Assurance Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
Knowledge and experience in manufacturing, project management and engineering. Good written and oral communication skillinteractioncellent problem solving and analytical skills Must possess excellent oral and written communication skills, and supervisory/leadership capability. Ability to handle multiple projects simultaneously in an unsupervised environment. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We encourage people with the creativity and aim to help us reinvent the future of health.
At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit /careers Becton, partinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, interaction, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or interactionual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PDN Primary Work Location USA NJ - Franklin Lakes Additional Locations Work Shift Apply Save Job PDN-9a068c7f-b5ff-410f-b193-ee372916692b
the formatting of procedural and technical documents, MBRs, and other GMP related documents. Process documents through the Veeva Quality Management System according to corporate and site procedures. Manage and track a large number of documents to completion.
Undertake any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood. Skills: General GMP knowledge Exceptional organizational and time management skills a must Project management skills required. Experience using Quality Management System(s) such as Veeva Vault. Exceptional knowledge
of Microsoft Word including shortcuts and formatting tools. Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
Strong collaboration and communication skills Ability to successfully work within strict timelines. Education: Minimum Associates Degree The ideal candidate will have : Experience using Quality Management System(s) such as Veeva Vault. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral
bonus program for referrals that we successfully place with our clients, subject to program guidelines.
ASK ME HOW. Thank you! PATHAN SAMIULLAHKHAN Lead - Recruitment-xyz X PAY RANGE AND BENEFITS: Pay range: $40 - $50/hr Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & shop coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) Clearly Rated Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website : / Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, interaction, age, physical or mental disability, veteran status, marital status, domestic partner status, interactionual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.
If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-xyz X. Please indicate the specifics of the assistance needed.
Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (Hire Genics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U. S. C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws. American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.
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to laboratory safety protocols. Ability to operate various lab equipment Organize and maintain flavor library Skills Strong Math Skills Knowledge of Excel and Word SAP Knowledge Strong Verbal & Communication skills Experience High School Diploma At least 1 year Lab experience 2 years Compounding Experience PDN-9ad9c417-949c-45cf-9552-5201446035a7
disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n Biotech, Inc. is part of the Janssen medical Companies.
Janssen Biotech, Inc. one of the Janssen medical Companies of Johnson & Johnson, and Legend Biotech USA Inc. have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational
treatment. In this role, you will be providing quality oversight for daily activities related to the production of cryopreservation of human apheresis and testing of viral vectors in a controlled c GMP environment.
You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our medical products? Apply today for this exciting opportunity! Main Responsibilities will include, but are not limited to: Partner with Operations teams
to support production activities related Advanced Therapy products in a c GMP manufacturing facility.
Perform review of production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies. Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner. Support change management processes including formal change controls by evaluating the proposed changes, backssing impact, and providing quality input on implementation plans. Author and revise Quality departmental documents. Review and approve controlled documents including standard operating procedures, master batch records, work instructions, protocols and reports, and technical studies.
Participate in continuous improvement activities. Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment. Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts. Other duties may be assigned as necessary. Education: A minimum of a Bachelor's Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred. Skills & Experience: Required: Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or medical industry, is required.
Knowledge and solid understanding of current Good Manufacturing Practices (c GMP) regulations and FDA/EU guidance Ability to be organized and capable of working in a team environment with a positive demeanor. A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills. Ability to work independently on routine tasks. Ability to maintain written records of work performed in paper-based and computerized quality systems.
Preferred: Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred. Experience with the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices is preferred. Other: Requires ability and flexibility to work 10-hour shifts 2nd shift. Work Tues-Fri 2nd shift (10 hours) one week, Work Wed-Sat 2nd shift (10 hours) other week, and repeat and provide occasional off shift support, as needed. This position is located primarily in Raritan, NJ, and may require up to 5% local travel.
The anticipated base pay range for this position is $60,000 to $96,600 Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.. #CAR-T
the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n medicals, LLC is part of the Janssen medical Companies. The QA Lab Oversight role is an exempt level position with responsibilities for providing quality oversight for Raritan site Quality Control laboratories.
The responsibility includes reviewing and approving, of standard operating procedures (SOPs)/ Forms, validation/ qualification/ method transfer protocols/ reports, completed assay data for testing of pre-clinical, clinical, and commercial stage CAR-T cellular therapy products tested in QC labs which includes In Process, Release, Critical Reagents
and Microbiology labs, Monthly Lab audits, initial approval for retest for SST/AAC/ SAC failures. Closure of QIs related to SST/AAC/ SAC. Key Responsibilities: Provides quality oversight for site Quality Control laboratories responsible for testing clinical and commercial stage CAR-T cellular therapy products in accordance with J&J policies, standards, procedures, and Global c GMP.
Work with QC organization to support the successful transfer of QC Lab functions to the Raritan c GMP facility to test products. Review and approve Technical Documents, Investigational Reports, Completed Daily Assay Data, Personnel Gowning and Pipette Qualifications, Data Generated Reports and Co A's as
applicable. Support the release of patient sample materials. Provide Quality feedback to QC Management by performing spot-checks in the QC Laboratories to ensure compliance.
Strive to reduce non-conformances in supported areas by proactively driving compliance. Strengthen QC Culture and recognize patterns/trends in Shop floor behaviour, reported data and communicate to management trending issues for improvement opportunities. Provide mentorship to other employees in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities. Routinely recognize and resolve quality issues. Seeks management perspective on quality issues.
Act as liaison for the quality team to guide and improve site improvement projects and strategies. Learn and develop within the business as a Subject Matter Expert on quality assurance topics. Perform tasks in a manner consistent with the safety policies, quality systems and c GMP requirements. Education: Minimum of a Bachelor's Degree required; focused degree in Science or Engineering Technologies preferred Experience and Skills: Required: A minimum of 4 years relevant work experience is required. Knowledge of Gx P regulations and FDA/EU guidance related to manufacturing of biomedicals.
Ability to quickly process information and make critical decisions with minimal oversight. Ability to independently be responsible for a portfolio of ongoing projects. Ability to pay attention to details and follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive approach under some supervision. Ability to summarize and present results, and experience with team-based collaborations is a requirement. Ability to identify/remediate gaps in processes or systems. Experience with cell and/or gene therapy analytical technique (e.
g. flow cytometry, q PCR) Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). Ability to work with others in a team environment and strong interpersonal and written/oral communication skills. Preferred: Experienced in c GMP aseptic manufacturing environments, preferably in quality control, quality assurance, manufacturing, compliance, clinical quality, or cell and gene therapy Detailed knowledge and understanding of current Good Manufacturing Practices (c GMP). Knowledge of current Good Tissue Practices (c GTP) related to CAR-T manufacturing or cell processing Detailed knowledge of CAR-T QC test methods and related equipment is helpful.
Proficient in applying process excellence tools and methodologies (Six Sigma), such as MES, SAP, PAS-X or similar. Other: Requires ability and flexibility to work 8-hour shifts between the operational hours of 8:00 AM - 5:00 PM Monday - Friday, and provide occasional support including nights, weekends, or other shifts with little or no prior notice This position is anticipated to have up to 10% travel The salary for this position is anticipated to be between $75,000 - $110,000.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.. #car-t
Quality Assurance (QA) jobs involve ensuring that products or services meet certain standards of quality before they reach the consumer. Individuals in QA roles are responsible for planning and implementing inspection processes, conducting tests, and analyzing the results to detect defects. They work to prevent errors and improve the overall quality of the final output. Key characteristics of QA jobs include attention to detail, a systematic approach to problem-solving, and a strong understanding of industry-specific regulations and quality standards. These professionals play a critical role in customer satisfaction and maintaining the reputation of a brand or company.
Biotechnology Compensation: View salary Total position: 1 Relocation assistance: No Visa : Only US citizens and Greencard holders This position reports to the Quality Assurance Manager.
Responsible to perform Quality Assurance activities in support of Quality Systems and/or client procedures including but not limited to client specific document management, issuance, investigation, CAPA, creating/updating SOPs, Qualification and Validation Reports, etc.
Attends project kick off meeting, as well as weekly project meeting. Participate in to tech transfer activity. Represent quality department during client meetings. Work with trifunctional department to ensure project related activity
is completed on time. This role supports internal and external audits which may include interaction with Health Authorities and clients. Essential Functions and Responsibilities Below is the summary of the role responsibilities.
This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Attends project kick-off meetings to understand the scope of the project. Creates, updates, reviews
and/or approves project related documents such SOPs, Batch release templates, label templates, batch records, change controls, etc.
according to client requirements and project scope. Participates in tech transfer activity to ensure adherence to company quality system standards. Proactively identifies risk and prepares mitigation strategies associated with project and client work. Represents QA Client Services during scheduled meetings with client and cross functional department. Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule.. Participates in client meetings and monitor quality activities of internal team members as they relate to contract deliverables.
Draft initial Quality agreement and complete necessary revisions based on client and company requirements. Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate. Provides quality data to Project Manager for the purpose of creating KPI metrics. Builds rapport with clients and troubleshoots issues of concern with internal team in order to provide the highest quality services which meet the needs and requirements of our clients.
Updates and maintains accurate information for each client on project-related documentation repository (i. e. Share Point). Communicates internally within QA team to provide key updates on project status, timelines, and deliverables. Formulates and prioritizes appropriate responses to client requests or concerns. Trains Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline. Supports, participates and follows up appropriately to internal, regulatory agency and client audit requests on a timely basis. Identifies and supports continuous improvement opportunities working cross departmentally or cross functionally n order to enhance operations.
Other duties may be assigned Qualifications Bachelor's Degree in Life Sciences Minimum 5 years experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred. Experience in authoring, reviewing, and /or approving c GMP/c GTP related documents (Investigation report, CAPA report, SOPs etc. ) required. Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
Familiar with FDA, ISO, and other regulatory agency guidelines. Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required. Working knowledge and technical understanding of aseptic manufacture of biologics preferred. Experience in both clinical and commercial manufacturing is preferred. Experience participating health authority inspections and/or client audits preferred. Experience in organizing teams for effective and timely completion of projects. Competencies/Candidate Profile Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.
Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions. Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
Composure: Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress; is not knocked off balance by the unexpected; doesnt show frustration when resisted or blocked; is a settling influence in a crisis. Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.
as engineering and process changes. This person will support the validation roadmap for the site. This role will also support Design Transfer/Change Control projects as needed. This role requires excellent organizational skills, analytical problem-solving skills, the ability to effectively communicate at a technical level as well as with management, and in-depth understanding of quality system requirements.
Responsibilities This position will be responsible for being the Quality Assurance lead for Validation as well as supporting Design Transfer and other change projects, including engineering and process change projects. The person in this role will: Support validation process through
protocol drafting, approval and execution and providing validation training and guidance Chair Process Change Review Board and participate in Validation Review Board meetings Participate in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead Lead improvement initiatives for Quality Assurance Independently perform full range of standard work Identify and resolve more complex problems and apply problems-solving skills in order to handle most situations Use statistical analysis and risk management techniques Provide guidance for process changes, including guidance on validation requirements Lead CAPA investigations Required Knowledge/Skills, Education, and Experience
In depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV , with ability to develop and support creation of protocols and reports Proven ability to lead projects In-depth knowledge of requirements related to ISO 13485 and FDA QSR Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control Experience with product transfers and new product development projects Experience with problem solving techniques and CAPA investigations Strong organizational skills and ability to prioritize Experience working in medical device or regulated industry Proficient with Microsoft Excel , including use of pivot tables Perform statistical analysis using standard software such as Minitab Ability to make decisions and communicate effectively to multiple levels Preferred Knowledge/Skills, Education, and Experience Bachelor's degree in Science or Engineering field of study Certified Quality Engineer (CQE) Six Sigma Certification experience preferred 5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above PDN-9ad5bce0-2f28-4f83-9e6b-5437b2d8f046
by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow n Biotech, Inc.
is part of the Janssen medical Companies. Janssen Biotech, Inc. one of the Janssen medical Companies of Johnson & Johnson, and Legend Biotech USA Inc. have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance
the promise of an immunotherapy CAR-T platform and investigational treatment. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our medical products?
Apply today for this exciting opportunity! The QASF Associate II is responsible for on the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled c GMP cleanroom environment. Key Responsibilities: • Provide Oversight and Support to clean room activities. • Provider QA shop floor support (Grad-B/ISO-7) for extended periods of time. • Work with Process Development team and Operations organization to successfully
transfer process to c GMP facility to manufacture products. • Support drafting of standard operating procedures and batch records.
• Approve printed documents prior to use on the manufacturing floor. • Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised. • Real time review of all documentation and reporting in support of process unit operations. • Support material release in SAP for In-house reagents. • Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented. • Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and c GMP requirements. • Organization of Document Control room and preparation of completed Batch Records documents retransfers QA Document Control and Archival • Monitor warehouse, manufacturing, and manufacturing support activities for CG MP compliance through spot checks/internal audits. • Other duties will be assigned, as the need arises. • Support the Shop Floor Order review and Closure process for executed batches and In House reagents/intermediates.
• Responsibilities will include but not limited to tasks mentioned above. Education: Minimum of a bachelor's or equivalent University Degree required; focused degree preferred in Science, Biology/Biotechnology, Cell/Gene Therapy, or equivalent technical field. Required: • Minimum 2 years of relevant work experience. • Quality Assurance experience within medical or a related industry. • Knowledge and solid understanding of current Good Manufacturing Practices (c GMP) regulations and FDA/EU guidelines. • Highly organized, with demonstrated attention to detail and ability to follow the procedures with minimal direction.
• Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment. • Proficient verbal communication skills, with the ability to optimally summarize and present results. Preferred: • Experience with aseptic processing in ISO 5 clean room. • Knowledge of c GMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. • Good written and verbal communication skills are required. • Ability to summarize and present results, and experience with team-based collaborations is a must.
• Ability to collaborate well with stakeholders, customers, and peers. • Ability to manage conflict and issues that arise with internal or external customers. • Ability to handle multiple tasks on same time. • Familiarity with SAP, MES (electronic batch records), Track Wise (quality event management), or equivalent systems. Other: Requires ability and flexibility to work 10-hour shifts between the operational hours of 7:30 AM - 6:00 PM/2:00PM-12:30 AM (Sunday-Wednesday/ Wednesday - Saturday), and provide occasional support including nights, weekends, or other shifts with little or no prior notice.
This position has an estimated annual salary of 61,000- 110,000. Requiresthe ability to meet the physical demands (lift to 20 lbs. stand or sit for extended periods of time in a clean room environment), to perform visual inspections of materials (color, appearance, particles, etc. ) and to document observations during manufacturing. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
