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Senior Quality Control Manager

2 months ago


Michigan, United States EPM Scientific Full time

Senior Quality Control Manager, Microbiology and Sterility Assurance

Position Overview: In this position, you will be responsible for overseeing the microbiology quality control laboratory's operations, with an emphasis on monitoring essential environmental parameters, conducting sterility assessments, and implementing specialized microbiological evaluations. Your role will involve ensuring adherence to industry regulations, managing laboratory functions, collaborating with cross-functional teams, and supervising the validation of innovative methods and equipment. Additionally, you will cultivate relationships with external laboratories and strategize for future laboratory improvements.

Essential Qualifications:

  • Bachelor's degree in Biological Sciences or a related discipline.
  • Demonstrated experience in managing pharmaceutical laboratory operations and regulatory engagements.
  • A minimum of 10 years of experience in regulated laboratory settings or pharmaceutical manufacturing.
  • Thorough knowledge of industry standards and regulations, including cGMP, FDA, and international guidelines.

Desirable Qualifications:

  • Bachelor's degree in Microbiology or a comparable field.

Key Responsibilities:

  • Lead and mentor a team of QC Microbiology professionals, encompassing recruitment, training, and performance evaluation.
  • Formulate and execute resource plans for personnel, facilities, and equipment to satisfy operational requirements.
  • Enhance laboratory compliance, efficiency, and service quality through proactive management and continuous improvement initiatives.
  • Collaborate with project teams to provide timely laboratory support and identify future technological and staffing needs.
  • Oversee investigations into laboratory and environmental concerns, ensuring effective corrective and preventive actions are implemented.
  • Assess the impact of microorganisms on processes and the efficacy of contamination control strategies.
  • Manage laboratory method development, validation processes, and vendor evaluations to ensure quality and compliance.
  • Review and evaluate new projects to ensure the laboratory is prepared to support future business expansion.