Senior Quality Control Microbiologist

Job Responsibilities:

• Perform and oversee routine and non-routine microbiological testing, including bioburden, endotoxin, sterility, microbial identification, growth promotion, and environmental monitoring.
• Lead investigations for microbiological deviations, out-of-specifications (OOS), and out-of-trends (OOT), including root cause analysis and CAPA development.
• Review and approve microbiological test data, reports, and batch records for accuracy and compliance with GMP requirements.
• Support contamination control initiatives and provide technical microbiology expertise to cross-functional teams.
• Maintain and optimize the environmental monitoring program, including cleanroom classification, microbial trending, and periodic risk assessments.
• Oversee qualification and routine maintenance of microbiology lab equipment (e.g., incubators, autoclaves, particle counters) and ensure proper documentation.
• Author, update, and review SOPs, test methods, protocols, and reports.
• Train and mentor junior microbiologists, providing guidance on lab techniques, GMP practices, and technical troubleshooting.
• Support regulatory inspections and internal audits as the subject matter expert (SME) for microbiology and environmental monitoring.
• Participate in method transfers, method validations, and continuous improvement projects.

Qualifications:

• Bachelor’s or Master’s degree in Microbiology, Biology, or related life sciences field (PhD a plus).
• 5–8 years of experience in a GMP microbiology or QC environment, preferably in pharma/biotech or medical devices.
• Strong working knowledge of USP, EP, ISO, and FDA/ICH regulatory guidelines.
• Hands-on experience with aseptic techniques, plate reading, EM programs, and routine microbiology assays.
• Demonstrated experience leading investigations and writing technical reports.