Senior QC Microbiologist

Job Title: Senior QC MicrobiologistLocation: Mundelein, ILJob 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.