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. #J-18808-Ljbffr