QC Microbiologist

Who You Are
The QC Microbiologist I ensures contamination control of manufacturing facilities by performing environmental and water sampling/testing per USP and EP requirements where applicable. Ensures timely and accurate material testing while maintaining quality and compliance.

Responsibilities
- Support manufacturing operations including process validation, environmental monitoring, and utility systems sampling/testing
- Perform environmental, water, and other utility sampling procedures
- Perform in-house microbiological assays
- Evaluate microbiological results including microbial identification as needed
- Prepare timely analytical lab reports/summaries
- Conduct Environmental and utility out-of-specification (OOS) investigations as needed
- Operate the autoclave to supply sterile testing materials
- Ensure laboratory testing materials are readily available
- Schedule and coordinate shipping of samples to contract laboratories
- Troubleshoot instruments; coordinate with lab manager/equipment technical services; perform maintenance and calibration verification/standardization per SOPs

Minimum Requirements
- Working knowledge of cGMPs, USP, EP, and other regulatory requirements for microbiology activities
- Proficiency in viable/non-viable environmental monitoring (gram staining, sub-culturing, bioburden testing, gowning, aseptic technique)
- Ability to work independently and with a team
- Microsoft Office (computer application skills)

Preferred Requirements
- Bachelor’s degree in microbiology, biology, biochemistry, or related discipline
- 2+ years relevant microbiology lab experience with aseptic processing
- Familiarity with Trackwise, MasterControl, and LIMS
- Pharmaceutical GMP experience

Job Location
- In-person from Research Triangle Park, NC facility 100% of the time.