Senior Quality Control Manager

2 weeks ago


Michigan, United States EPM Scientific Full time

Position Title: Senior Quality Control Manager, Microbiology and Sterility Assurance

Role Summary: In this position, you will be responsible for overseeing the microbiology quality control laboratory operations. Your primary focus will be on monitoring essential environmental parameters, conducting sterility assessments, and performing specialized microbiological analyses. Key responsibilities include ensuring adherence to industry regulations, managing laboratory workflows, collaborating with interdisciplinary teams, and supervising the validation of innovative methods and equipment. Additionally, you will cultivate relationships with external laboratories and strategize for future laboratory improvements.

Required Qualifications:

  • Bachelor's degree in Biological Sciences or a related discipline.
  • Demonstrated experience in managing laboratory operations within the pharmaceutical sector and engaging with regulatory bodies.
  • 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.

Preferred Qualifications:

  • Bachelor's degree in Microbiology or a closely related field.

Core Responsibilities:

  • Lead and mentor a team of QC Microbiology specialists, including recruitment, training, and performance evaluation.
  • Formulate and execute resource strategies for personnel, facilities, and equipment to align with operational requirements.
  • Enhance laboratory compliance, productivity, and service quality through proactive management and continuous improvement initiatives.
  • Work collaboratively with project teams to provide timely laboratory support and identify future technological and staffing needs.
  • Oversee investigations into laboratory and environmental challenges, ensuring effective corrective and preventive actions are implemented.
  • Assess the influence 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.


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