Hiring: Supervisor, Quality Control - Microbiology Company: FUJIFILM Biotechnologies Location: Durham, NC Job Posted Time: 2026-09-13 12:04:17 Target Skills & Keywords : Microsoft Office, Root Cause Analysis, Six Sigma About the job Experience: •4 years of experience in a cGMP environment •At least 4 years of experience in a cGMP environment Required Skills: •People Leadership •Supervise, coach, and develop 6–12 QC Micro analysts; manage scheduling, training, performance feedback, and career development. •Maintain team qualification matrices; ensure training is current and effective. •GMP Testing and Lab Operations •Oversee Environmental Monitoring/utility programs (viable/non-viable monitoring, compressed gases, WFI/PW/clean steam). •Ensure timely and compliant execution of compendial and in-house methods: bioburden, endotoxin (LAL), sterility, growth promotion, microbial ID, total counts, AET/MVT, microbial limits, particulate testing, disinfectant efficacy, TOC/conductivity as applicable. •Review and approve data, test records, LIMS entries, and COAs; ensure ALCOA+ data integrity. •Manage sample logistics, inventory, and equipment readiness (calibration, PM). Qualifications: •Environmental monitoring in ISO/Classified spaces and utilities testing. •Sterility testing (e.g., USP ), endotoxin/LAL (USP ), bioburden/microbial limits (USP /), growth promotion, microbial ID (e.g., MALDI TOF), AET/MVT, and data trending. •Deviation/OOS/OOT investigations, root cause analysis, and CAPA management. •Operational familiarity with LIMS/ELN, TrackWise or similar eQMS; proficiency with MS Office/Teams. •CGMP, data integrity (ALCOA+), ICH Q7/Q9/Q10, USP/EP/JP, and EU Annex 1 (2022). •Strong leadership, prioritization, communication, and cross functional collaboration. •Demonstrated capacity to operate in a fast paced, shifting priority environment and make sound, risk based decisions. •Bachelor’s degree in Life Science or Biology with at least 4 years of experience in a cGMP environment •Will work in environment which may necessitate respiratory protection •Demonstrated capacity to discern audible cues Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!