Manager, Quality Control

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, “right first time” 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; escalation 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: Bachelor’s 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. #J-18808-Ljbffr