Location: Janesville, WI
Company: The Employee Connect
activities relating to customer complaints, including customer interface, immediate response actions, root cause analysis, corrective/preventive actions and follow-up. Identify, prevent, and analyze defects, both internal and external. Track internal and external defects and report this information for problem-solving analysis, error proofing and continuous improvement.
Review and approve PPAP submissions to customers. Assist production with PPAP builds to ensure all customer requirements are met. Support APQP activities for new product launches and product/process changes. Conduct internal Quality Audits and external Supplier Audits, reporting findings and assisting on corrective actions.
Participate in continuous improvement initiatives including scrap and labor reductions and elimination of redundant inspections. Lead communication and resolution of vendor-related issues.
Train/educate the workforce on Quality principles. Support, promote, and perform in a manner consistent with continuous improvement goals and the values of DSB Technologies. Experience you will need: Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering. 3-5 years of related experience. Certified Quality Engineer (CQE) certification. Six Sigma experience. Ability to read and interpret customer drawings and specifications. Data driven mindset. Excellent communication
skills, both internally and externally. Strong analytical skills, strategic thinking ability, and problem-solving capacity.
Good team player with an ability to function in a cross functional organization. Proven ability to manage deadlines, prioritize, multi-task. Ability to troubleshoot issues, find root causes and initiate corrective actions.
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.
Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality &
Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.
The Quality & Compliance Senior Specialist I works closely with c GMP groups throughout the facility in order to perform internal audits, and to client audits and regulatory inspections. The Senior Specialist I also works directly with clients to support audits and inspections, as well as to develop process validation documents to support the client project moving from clinical to commercial. The Quality & Compliance team is responsible for ensuring the site remains regulatorily compliant and always inspection
ready. This is a full-time on-site salaried position, Monday - Friday 8:00am to 5:00pm Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role: Oversees the internal audit program, including coordinating the audit with relevant department subject matter experts, performing in-depth backssments of systems and procedures; communicating audit findings to key stakeholders; assisting with the development and review of audit responses Oversees the customer audit program, including coordinating audits with the customer and internal stakeholders; hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response and follow up actions Monitors and backsses changes to regulatory guidance and compendial monographs Provides support to ensure that the quality systems are maintained in compliance with regulatory and customer requirements as well as corporate requirements.
Supports and enhances effectiveness of the quality system, including developing and reporting metrics; developing and authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes Drafts, reviews, executes, and approves technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.
g. PPQ, CPV, APR / PQR) All other duties as assigned The Candidate: Requires Doctorate Degree in STEM discipline with minimum of 7 years related experience, OR Master's Degree in STEM discipline with minimum of 10 years related experience, OR Bachelor's Degree in STEM discipline with minimum of 15 years related experience, OR Associate's Degree in STEM discipline with minimum of 17 years related experience.
Knowledge of c GMP, ICH, FDA, EMA regulations or guidelines. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to xyz X@.
This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U. S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.
Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U. S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.
If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to xyz X@ for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
to automate. Execute software testing across all product lines. Facilitate business user testing activities and sign off of all new product and feature development. Accurately and consistently track defects and work with the engineering team to provide context and support in the resolution of defects and execute re-testing.
Assist with business user training as new features and products are implemented. QUALIFICATIONS: 3+ years experience working as a Quality Analyst Experience in analytics, high level problem solving skills and the ability to maintain a high level of internal customer satisfaction. Support the implementation of best practices in software testing. Experience with various automated testing solutions. Interested candidates can send their updated resumes at xyz X@global- Job Posted by Applicant Pro
in project implementation and reliability improvement of the product.
Proficiency in Microsoft Office is required Education and Experience Requirements Bachelor's Degree in Engineering, aviation sciences, quality systems, or a related field required or equivalent combination of education and experience sufficient to successfully perform the essential functions of the job.
4 years technical related experience in a manufacturing environment, or repair and overhaul facility. Position Purpose : The Supplier Quality Engineer (SQE) is responsible for addressing all quality performance related concerns for suppliers throughout the product life cycle. The SQE works with suppliers to monitor
the effectiveness of their Quality Management System and partners with key stakeholders such as Engineering, Operations, and Procurement to continuously improve supplier performance (increase lifecycle, reduce scrap, improve manufacturing/repair processes).
This position requires leadership skills that would enable the SQE to drive major Quality improvement projects across functions with minimum supervision. Job Description Principle Duties and Responsibilities: Essential Functions: Performs all tasks in area of responsibility in a timely manner to support the supplier quality/inspection system. Ensures all aspects of the delivered/finished article is manufactured in accordance with approved
quality system requirements and is certified as compliant to type design requirements or compliant with in-service limitations for Repair Station activities.
Manages the compliance of supplier performance through the application of system, product and process audits in accordance with company policy and federal regulations. Certifies a supplier or backss supplier quality system, personnel, processes and equipment as required. to the applicable quality standards. Coordinates quality assurance program plans, monitors and modifies audit schedules, evaluates acceptance test programs, and quality engineering requirements of Gulfstream suppliers.
Responsible for driving the Corrective Action and Preventive Action (CAPA) process for all Suppliers. Promotes the use of continuous improvement techniques and APQP principles at Suppliers to help them reduce variability and achieve process control. Additional Functions: Drives closed loop corrective action process and ensure timeliness and effectiveness of supplier CA plans.. Develops key metrics and score card measures that accurately depict supplier health from a risk and performance perspective.. Provides technical guidance and direction to subordinate level personnel. Oversees completion of assigned tasks of subordinate level Quality Engineers within functional groups.
Lead quality focus meetings to address supplier performance and to communicate progress to senior leadership.. Perform other duties as assigned. Other Requirements: An Airframe & Powerplant (A&P) License may be used in combination with four years of related experience (in addition to the experience requirements below in lieu of the degree requirement. ASQ certification (CQE) and/or experience as a FAA recognized designee highly preferred. Understands and is able to apply and communicate to others: blueprints/specifications; Federal Aviation Regulations; Quality Control System Requirements; knowledge of manufacturing/fabrication techniques and processes.
Computer literate; capable of working within the various software applications utilized throughout the enterprise. Experience in a Supplier Quality capacity highly desirable. Advanced knowledge of Lean/Six Sigma principles (certification preferred). Working knowledge of APQP principles and the ability to lead and train others related to the skillset. Additional Information Requisition Number: 216959 Category: Quality Assurance Percentage of Travel: Up to 25% Shift: First Employment Type: Full-time Posting End Date: 01/31/2024 Equal Opportunity Employer/Veterans/Disabled.
Gulfstream does not provide work visa sponsorship for this position, unless the applicant is a currently sponsored Gulfstream employee. Legal Information Site Utilities Contacts Sitemap Copyright © 2023 Gulfstream Aerospace Corporation. All Rights Reserved. A General Dynamics Company. Gulfstream Aerospace Corporation, a wholly-owned subsidiary of General Dynamics (NYSE: GD), designs, develops, manufactures, markets, services and supports the world's most technologically-advanced business jet aircraft
