Associate Specialist, Quality Assurance
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Specialist in Quality Organization is responsible for providing compliance oversight to the vaccine manufacturing area while actively supporting, participating in and embracing an empowered team culture.
The West Point Quality rotational program is a two year program that will provide experience in the following areas: Quality on the production and laboratory shop floor, Compliance to regulatory guidelines, Regulatory agency and Internal Audit support processes.
This is a cohort program with the first rotation starting at the hub of Quality Assurance in the Internal Audit organization where incumbents will be physically present on the shop floor and assist with improving compliance. The second rotation will depend on business need in operational areas and the incumbent will be responsible for day to day quality in-line support.
Each cohort class will have the opportunity to further develop and apply their technical knowledge through a variety of projects and learning opportunities within Manufacturing and/or the Quality Control Laboratories. Rotational opportunities may include off-shift/off-schedule support.
• Contributes to the performance and results of a vaccine manufacturing department.
• Provides regulatory, quality and compliance guidance.
• Applies technical, collaboration and interpersonal skills to align activities with department objectives.
• Works as a team member on shop floor audits, quality systems activities and/or process improvement projects.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Assures consistent application of standardized work, process tools, and procedures.
• Assists with regulatory inspections in either documentation area, request management area or inspection room.
• Provides quality guidance to technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Effectively collaborates with peers on site and above site as required.
Education Minimum Requirement:
B. S. Degree in Engineering or Sciences
Required Experience and Skills:
• Communication, leadership and teamwork skills.
Preferred Experience and Skills:
1. Experience in biologics, vaccine or bulk sterile manufacturing facilities.
2. Experience using Lean/Six Sigma tools.
3. Capabilities for managing multiple tasks simultaneously, including leading small projects.
4. Experience in a GMP regulated facility or laboratory
5. Internship or Co-op experience with Merck
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need an accommodation for the application process please email us at firstname.lastname@example.org.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
Job: Qual Assurance & Ops Generic
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck