Lead Microbiology QC Supervisor – GMP & Bioburden

Biopharma Careers; St. Louis (MO); On-site; USD 86,000 - 136,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Other perquisites

Job summary

MilliporeSigma is seeking a Microbiology Supervisor to lead the GMP QC Microbiology department, ensuring ICH Q7 and 21 CFR compliance for API testing. You will oversee test methods, validations, tech transfers, OOS/OOT investigations, deviations, CAPAs, and aseptic techniques training.

You will manage a QC Microbiology team of 8–10, monitor Environmental Monitoring and Bioburden/Endotoxin labs, and drive quality improvements and audits. Strong communication with stakeholders is required.

Qualifications

• Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline.
• 3+ years of experience as a quality control manager, supervisor, or lead.

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.

Job description

MilliporeSigma is seeking a Microbiology Supervisor to lead the GMP QC Microbiology department, ensuring ICH Q7 and 21 CFR compliance for API testing. You will oversee test methods, validations, tech transfers, OOS/OOT investigations, deviations, CAPAs, and aseptic techniques training.

You will manage a QC Microbiology team of 8–10, monitor Environmental Monitoring and Bioburden/Endotoxin labs, and drive quality improvements and audits. Strong communication with stakeholders is required.