Job Summary:
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.
Key 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.
Compile environmental monitoring data, perform trend analysis, and prepare routine reports.
Assist in preparing, reviewing, and updating SOPs, protocols, and laboratory documentation.
Participate in internal audits, training activities, and continuous process improvement initiatives.
Education:
Bachelor's degree in microbiology, Biology, Biotechnology, Life Sciences, or a related scientific discipline preferred. Relevant industry experience may be considered in lieu of a degree.
Required Experience:
1-3 years of experience in microbiology, environmental monitoring, or quality control laboratory operations.
Experience working in GMP-regulated pharmaceutical, biotechnology, or medical device environments preferred.
Familiarity with cleanroom practices, aseptic techniques, and microbiological testing methods.
Strong documentation skills and knowledge of GMP documentation practices.
Ability to work independently and collaboratively in a laboratory environment.
