Senior QC Microbiologist

Job Title: Senior QC Microbiologist

Location: Mundelein, IL





Job Summary:

Seeking a Senior GMP Microbiology Consultant with 10+ years of pharmaceutical/biotech microbiology experience to assess a GMP QC microbiology laboratory supporting
product release and environmental monitoring.





Key Responsibilities:


- Perform GMP laboratory assessments/audits.
- Review QC microbiology, product release, bioburden, and environmental monitoring activities.
- Evaluate microbial testing, identification, media preparation, and growth promotion.
- Review method validation, verification, suitability, and transfer.
- Assess laboratory equipment qualification, calibration, and maintenance.
- Review OOS/OOT, deviations, contamination events, investigations, CAPA, and trending.
- Evaluate data integrity, ALCOA+, GDP, and laboratory documentation.
- Assess contamination control, laboratory workflow, and facility practices.
- Identify GMP compliance gaps and risks and recommend corrective actions.
- Prepare assessment reports and remediation recommendations.
- Present findings to Laboratory, Quality, Manufacturing, and management teams.






Required Skills & Experience:


- Bachelor's degree or higher in Microbiology, Biology, or related field.
- 10+ years of GMP pharmaceutical/biotech microbiology experience.
- Strong QC Microbiology experience.
- Experience with Environmental Monitoring (EM) and product release testing.
- Experience with bioburden, microbial identification, and microbiological testing.
- Strong knowledge of FDA 21 CFR 210/211 and USP microbiology requirements.
- Experience with OOS/OOT, deviations, CAPA, contamination investigations.
- Knowledge of ALCOA+, data integrity, and GDP.
- GMP auditing/assessment experience strongly preferred.
- FDA inspection or regulatory audit experience is a plus.
- Previous Microbiology Manager, SME, Technical Lead, or Supervisor experience preferred.