Manager, Quality Control
Merck
Quality Control Manager (Environmental Monitoring & Qualified Utilities)
Responsibilities:
- Provide quality oversight of qualified utilities and facility environmental monitoring (EM) sampling at the West Point vaccine manufacturing site.
- Ensure Water-for-Injection, Clean Steam, and Compressed Gases and Facility EM (Surface, Air, Personnel Sampling) are sampled as required and remain in environmental control.
- Schedule, review, and evaluate testing data; collaborate with vaccine manufacturing to ensure timely, โright first timeโ completion.
- Manage technicians performing sampling; collaborate with shop steward and team lead to schedule compliant testing.
- Monitor performance vs. specifications; support manufacturing and laboratories.
- Participate in meetings; escalate concerns and share best practices.
- Develop/manage SOPs, departmental project protocols, and reports; lead/assist compliance and improvement projects.
- Ensure adherence to SOPs, cGMPs, and safety procedures.
Education:
- Bachelorโs degree in Biology, Engineering, or Chemistry (or equivalent with relevant experience).
Required experience/skills:
- 3+ years post-degree in Environmental Monitoring, Aseptic Manufacturing, or Microbiological/Analytical Laboratory Operations.
- Strong verbal/written communication and conflict resolution.
- Attention to detail; awareness of production/quality issues.
- Basic understanding of GMPs and regulatory requirements (vaccine/sterile pharma related).
Preferred:
- Managing/supervising teams; collaboration/inclusion; problem-solving; manage multiple tasks/projects.
Required skills (selected):
- cGMP compliance/regulations, deviation & corrective action management, driving continuous improvement, GMP, LIMS, instrumentation, people management, technical writing.
Compensation/benefits (if applicable):
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits include medical/dental/vision, retirement/401(k), paid holidays, vacation, and sick/compassionate days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.