Analyst II, QC Micro

Role: Laboratory microbiology technician supporting environmental/utility testing and quality systems within a biopharma manufacturing environment. Responsibilities include executing microbiological assays such as sterility, bioburden, endotoxin testing, environmental monitoring, and validation studies; investigating laboratory issues; maintaining compliance with ISO, USP, FDA, and EU regulations; and supporting GMP quality systems through audits, SOP updates, and trend analysis. Requirements: Bachelor’s or Master’s in applied science (microbiology preferred); 2-5 years’ microbiology lab experience, familiar with aseptic techniques, membrane filtration, microbial identification, and environmental monitoring; working knowledge of cGMP, CFR, USP guidelines; strong documentation and communication skills; proficiency in MS Office. Preferred: GMP manufacturing experience, microbiology assay expertise, and knowledge of validation and CAPA processes. HighValue: microbiology (sterility, bioburden, endotoxin), GMP manufacturing, environmental monitoring, validation studies, compliance with ISO, USP, FDA, EU regulations, and microbiology assay techniques. WorkSetup: likely on-site with possible weekend/night shifts; physical and mental demands relevant to laboratory testing environment.