Senior GMP Microbiology Lab Compliance Lead

United Pharma; Illinois; On-site; USD 130,000 - 180,000; Full time

Job summary

United Pharma is seeking an experienced microbiology QA leader to drive compliance across GMP operations. The role requires evaluating lab practices, ensuring data integrity, and guiding investigations into OOS/OOT events and contamination incidents.

Responsibilities include overseeing staff training, method validation, and coordination with Quality and Manufacturing to implement remediation actions. A strong background in FDA inspections and GMP microbiology is essential.

Qualifications

• Bachelor's degree or higher in Microbiology or related discipline.
• Advanced degree in Microbiology or related discipline preferred but not required.
• Minimum of 10 years of pharmaceutical/biotech microbiology laboratory experience, preferably GMP QC.
• Experience with laboratory investigations involving microbial excursions, OOS/OOT results, contamination events, and microbial identification.

Responsibilities

• Conduct comprehensive assessment of microbiology lab operations against FDA cGMP, USP, internal procedures, and industry practices.
• Evaluate lab organization, staffing, training, analyst qualification, supervision, and quality oversight.
• Review microbiological testing for product release, raw materials, utilities, environmental monitoring, and other programs.
• Assess microbiological methods for enumeration, testing, bioburden, identification, and method suitability.
• Review media preparation, growth-promotion testing, media storage, culture maintenance, reagents, and microbiological supplies.
• Assess lab equipment qualification, calibration, preventive maintenance, and routine controls (incubators, autoclaves, refrigerators, biosafety cabinets, etc.).
• Review sample receipt, handling, storage, chain of custody, testing, retention, and disposition practices.
• Review laboratory data integrity including raw data, worksheets, electronic systems, audit trails, calculations, and GDP.

Skills

Regulatory knowledge

GMP compliance

Audit experience

Technical writing

Education

Bachelor's degree in Microbiology or related

Advanced degree preferred

Job description

United Pharma is seeking an experienced microbiology QA leader to drive compliance across GMP operations. The role requires evaluating lab practices, ensuring data integrity, and guiding investigations into OOS/OOT events and contamination incidents.

Responsibilities include overseeing staff training, method validation, and coordination with Quality and Manufacturing to implement remediation actions. A strong background in FDA inspections and GMP microbiology is essential.