Full-time
Microbiologist
Pharma Universe
Chicago, illinois
The Microbiologist supports microbiology and environmental monitoring (EM) programs while ensuring compliance with cGMP regulations. This role involves hands-on laboratory work and collaboration with manufacturing processes for non-sterile and sterile products.
Key Responsibilities
- Perform environmental monitoring in controlled and aseptic manufacturing areas, collecting samples for viable and non-viable particle detection.
- Conduct routine water and steam system monitoring (WFI, RO, PW, CS) for TOC, conductivity, microbial counts, and endotoxins.
- Execute bacterial endotoxin testing, gram staining, growth promotion, bioburden, and microbial limit testing.
- Monitor and verify laboratory equipment, including refrigerators and incubators.
- Record and review microbiology data, conducting trend analysis in Excel.
- Investigate deviations, including OOS and EM Action/Alert Levels, and implement corrective...