Quality Control Microbiologist (2nd Shift)

Job Summary Under minimal supervision, serves as the technical subject matter expert (SME) for bacterial endotoxin testing. Independently performs, leads, and oversees BET activities for raw materials, in process materials, finished products, and stability samples in accordance with USP, ISO, and applicable compendial requirements. Responsibilities Act as BET SME for the laboratory, business divisions, and internal customers. Independently perform and lead endotoxin testing (gel clot, kinetic chromogenic/turbidimetric) for QC and R&D samples. Review and approve test data, calculations, and results for accuracy, completeness, and compliance. Lead OOS, OOCAL, deviation, and investigation activities related to endotoxin testing. Provide regulatory and audit support, including inspection readiness, technical justifications, and establishing product families for medical device products. Identify testing gaps, perform gap analyses, and drive risk based solutions. Mentor and provide technical...