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.

• Bachelor’s degree in Biology, Engineering, or Chemistry (or equivalent with relevant experience).

• 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).

• Managing/supervising teams; collaboration/inclusion; problem-solving; manage multiple tasks/projects.

• cGMP compliance/regulations, deviation & corrective action management, driving continuous improvement, GMP, LIMS, instrumentation, people management, technical writing.

• 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.