What are the responsibilities and job description for the Quality Control Microbiologist position at Meet?
Job Summary : The QC Microbiologist role involves performing microbiological testing, environmental monitoring, and utility sampling to ensure the quality and safety of pharmaceutical products and manufacturing processes. The successful candidate will be responsible for laboratory testing, routine QC operations, and supporting manufacturing activities in compliance with FDA regulations, cGMP, and other industry standards.
Responsibilities :
- Perform routine sampling of Water for Injection (WFI), Purified Water, Clean Steam, and Process gases to ensure quality control standards are met.
- Conduct environmental monitoring of cleanroom suites and laboratory areas, ensuring compliance with cleanliness and contamination control standards.
- Perform QC microbiology laboratory testing, including bioburden, endotoxin, sterility, and microbial identification tests for In-Process, Drug Substance, Drug Product, and Stability samples.
- Assist with routine QC operations such as instrument qualification, maintenance, SOP generation and revision, specification updates, and record keeping.
- Oversee inventory control for laboratory reagents and supplies to ensure availability and readiness for testing.
- Conduct investigations for Out of Specification (OOS), Out of Trend (OOT) results, deviations, and invalid assays, implementing corrective and preventive actions (CAPAs).
- Participate in facility qualification activities, including microbiological testing and environmental monitoring.
- Engage in method transfer and validation activities, contributing to protocol preparation, execution, and report generation.
Qualifications :
