Location: West Point
Company: Merck
Practices. The role will support various initiatives as the capital project progresses from commissioning and qualification through process qualification to eventual commercial manufacturing. Scope of work to include supporting electronic batch record development (MES), review of technical and production documents through the development lifecycle, provide direct support to the production floor and aid in the development and implementing of quality processes.
Additionally, the Quality Specialist may spend considerable time on the shop floor collaborating with Operations and Technology to enable RFT production, learn the manufacturing process, and ensure compliance with c GMPs and regulatory
requirements. The Quality Specialist should be knowledgeable in QMS, local SOPs, Health Authority requirements and c GMPs to ensure that the new facility is setup for successful licensure.
Expectations to train on and gain competency in activities to ensure quality and compliance for future product manufactured by the IPT. The Quality Specialist performs job functions primarily supporting the production shop floor in a team environment. Primary Responsibilities Quality review and approval of qualification documents. Development of SOP, MES Batch records, e Logs and other documents to support the start up a new manufacturing facility. Quality batch record review and approval (EBR). Quality
review and approval of master batch record updates (PAS-X/MES).
Critical site reviews for per process environmental monitoring. Quality review and approval of updated SOPs, Controlled Job Aids, e Logs. GMP walk through inspections within the IPT to ensure compliance with c GMPs and regulatory requirements. Assists with training of incoming personnel and ensures compliance with departmental procedures. Actively participates in the Tier process and uses this forum to escalate concerns and best practices. Works with IPT members in the identification and implementation of continuous improvement initiatives and action plans. Education Minimum Requirement Bachelor's Degree.
Degree in life science discipline or engineering field (preferred); candidates with degrees in other fieldswill be considered if accompanied by significant relevant experience. In lieu of Bachelor's degree as described above, equivalent direct experience of minimum 2-3 years relevant work experience in a GMP Manufacturing or Laboratory environment, in amedical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations. Required Experience and Skills Minimum 1-2 years of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, medical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, orrelated industry experience in a laboratory, manufacturing, science related or regulated setting.
Evidence of leadership skills coupled with good verbal and written communication skills. Understanding of c GMPs and regulatory requirements as they pertain to the medical industry. Preferred Experience and Skills Familiarity with GMP documentation review is a key skill necessary for success in this position. Quality assurance audits or inspection of vaccine or medical manufacturing areas.
NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, interaction, interactionual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
For more information about personal rights under the U. S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts U. S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U. S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely.
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as " remote" Search Firm Representatives Please Read Carefully Merck & Co.
Inc. Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Requisition ID: R272148PDN-9ae5db99-d5af-4ad1-a918-230f7946f160
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
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.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
