Microbiology QC Lab Leader — GMP Compliance

Millipore Corporation; St. Louis (MO); On-site; USD 77,000 - 116,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perquisites

Job summary

MilliporeSigma is seeking a Microbiology Supervisor to lead the GMP QC Microbiology department, ensuring compliance with ICH Q7 and 21 CFR for API testing. The role excludes visa sponsorship and requires US work eligibility.

You will oversee test methods, validations, tech transfers, CAPAs, and OOS/OOT investigations while managing a QC team of 8–10. Expect collaboration with audits and regulatory bodies to uphold quality standards.

Qualifications

• Bachelor's degree in microbiology, biochemistry, biology, or life sciences is required.

Responsibilities

• Oversee microbiological test methods, method validations, and tech transfers.
• Manage OOS/OOT investigations, deviations, and CAPAs.
• Conduct routine training on aseptic techniques and testing procedures.
• Supervise QC Microbiology team of 8–10 employees and ensure delivery of quality metrics.
• Oversee Environmental Monitoring and Bioburden/Endotoxin testing labs.
• Ensure timely product release by prioritizing lab testing schedules.
• Develop and implement quality systems and policies to improve product/ materials quality.
• Support client and regulatory audits.

Skills

Quality control

GMP

Analytical instrumentation

Laboratory software

Education

Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline

Tools

Analytical instrumentation

Laboratory software

Job description

MilliporeSigma is seeking a Microbiology Supervisor to lead the GMP QC Microbiology department, ensuring compliance with ICH Q7 and 21 CFR for API testing. The role excludes visa sponsorship and requires US work eligibility.

You will oversee test methods, validations, tech transfers, CAPAs, and OOS/OOT investigations while managing a QC team of 8–10. Expect collaboration with audits and regulatory bodies to uphold quality standards.