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 Line Oversight program is a multi-year program that will provide experience in the following areas: Quality on the production shop floor rotating through four vaccine filling/inspection and packaging departments to perform sample inspection work, line clearance activities and a wide variety of compliance oversight activities. The position rotates across all three shifts and does include weekend coverage.
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 Quality.
This is entry level position, but experience is highly preferred.
- 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.
- B. S. Degree in Engineering or Sciences
- Communication, leadership and teamwork skills.
- Experience in biologics, vaccine or bulk sterile manufacturing facilities.
- Experience using Lean/Six Sigma tools.
- Capabilities for managing multiple tasks simultaneously, including leading small projects.
- Frequently interacts with employees within own and from other departments.
- Experience in a GMP regulated facility or laboratory
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.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck