Job Description
Job Summary
The Microbiologist Quality Assurance is responsible for ensuring microbiological quality and safety of products, raw materials, utilities, and manufacturing environments. This role supports compliance with regulatory standards, GMP, and company quality systems through routine testing, monitoring, investigations, and documentation.
Key Responsibilities
- Perform microbiological testing of raw materials, in-process samples, finished products, and stability samples.
- Conduct environmental monitoring (air, surface, water, and personnel) in production and controlled areas.
- Monitor and trend microbiological data to identify deviations and risks.
- Investigate out-of-specification (OOS), out-of-trend (OOT), and contamination events; recommend and implement CAPA.
- Review and approve microbiological test results and reports.
- Ensure compliance with GMP, GLP, ISO, FDA, and other applicable regulatory requiremen...