The Microbiology Specialist I is responsible for supporting microbiological quality activities within GMP manufacturing environments. The role includes environmental monitoring, microbiological testing, data review, laboratory documentation, and ensuring compliance with regulatory and quality standards to support manufacturing operations. Responsibilities:
Perform routine environmental monitoring of classified cleanrooms during operational and non-operational conditions.
Collect and process environmental samples including air, surface, and personnel monitoring.
Conduct microbiological testing of media, utilities, raw materials, and in-process samples.
Identify microbial isolates using established laboratory procedures.
Support investigations involving environmental monitoring excursions and microbiological deviations.
Review, document, and maintain laboratory records in accordance with GMP requirements.
Assist with laboratory equipment calibration, maintenance, inventory, and housekeeping activities.