- Perform all microbiological assays
- Support Manufacturing operations; environmental monitoring, utility sampling/testing, and more.
- Review and Release microbial test results to ensure SOPs are compliant and data is accurate.
- SOPs: write, and review for compliance with equipment operation, methods, compendia.
- Resolve issues in a timely manner.
- Support RAM and ELPRO
- Train departments employees in operations and SOPs.
- Schedule and coordinate annual preventive maintenance/calibration of various Microbiological instruments.
- Complete OOS deviations as needed
- Other duties may be assigned.
- Bachelor's in microbiology, Biology, or equivalent training.
- 2+ years of experience in cGMP microbiology laboratory within the pharmaceutical industry.
- Experience in water sampling, and particulate monitoring.
- Bacterial endotoxin
- Aseptic Technique
- Bioburden testing by membrane filtration
- Sterility Testing using an isolator