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Microbiology Supervisor (QC Lab)

Merck•Saint Louis, MO
•Onsite
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About The Position

The Microbiology Supervisor leads the GMP Quality Control Microbiology department, ensuring full compliance with ICH Q7 and 21 CFR regulations for active pharmaceutical ingredient (API) testing. Key responsibilities include overseeing microbiological test methods, method validations, and tech transfers; managing OOS/OOT investigations, deviations, and CAPAs; and conducting routine training on aseptic techniques and testing procedures. Supervise, manage, and develop a QC Microbiology team of 8–10 employees, holding full accountability for meeting business quality performance metrics and KPIs. Oversee the Environmental Monitoring Program and the Bioburden and Endotoxin Testing laboratories. Manage and prioritize laboratory testing schedules to ensure all products are released in a timely manner. Develop and implement programs to establish and maintain quality systems and product/service standards, while driving quality improvement initiatives and establishing policies, procedures, and methods to enhance product, material, component, process, and operational quality. Support and participate in client and regulatory audits. Interface with internal and external customers on a regular basis to communicate project status, resolve issues, and implement methods, techniques, and evaluation criteria for products and processes. Perform other duties as required by management.

Requirements

  • Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline
  • 3+ years of experience as a quality control manager, supervisor, or lead
  • In-depth knowledge of health authority (FDA, EMA) expectations for pharma/biotech bulk and finished product manufacturing, alongside microbiological testing requirements
  • Proficiency with analytical instrumentation and laboratory software
  • Comprehensive knowledge of ICH Q7, 21 CFR 210/211, USP, and EP pharmacopeia requirements
  • Proven experience working in a highly matrixed organization, preferably within a GMP manufacturing environment
  • Strong written and verbal communication skills, with a demonstrated ability to translate complex issues into straightforward, succinct explanations
  • Advanced root cause analysis and problem-solving skills
  • Strong computer skills, including proficiency in word processing and Quality Systems databases
  • Subject matter expertise in aseptic principles and practices
  • Strong understanding of microbiological methodology and laboratory techniques, specifically USP <85>, USP <61>, and USP <62>

Nice To Haves

  • Master's degree in a Life Sciences discipline
  • Experience as a Quality Control Supervisor or Manager at a Life Sciences organization

Responsibilities

  • Supervise, manage, and develop a QC Microbiology team of 8–10 employees, holding full accountability for meeting business quality performance metrics and KPIs
  • Oversee the Environmental Monitoring Program and the Bioburden and Endotoxin Testing laboratories
  • Manage and prioritize laboratory testing schedules to ensure all products are released in a timely manner
  • Develop and implement programs to establish and maintain quality systems and product/service standards, while driving quality improvement initiatives and establishing policies, procedures, and methods to enhance product, material, component, process, and operational quality
  • Support and participate in client and regulatory audits
  • Interface with internal and external customers on a regular basis to communicate project status, resolve issues, and implement methods, techniques, and evaluation criteria for products and processes
  • Perform other duties as required by management

Benefits

  • health insurance
  • paid time off (PTO)
  • retirement contributions
  • other perquisites

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

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