Quality Control Microbiology Specialist

Role: Microbiology Lab Operations Specialist supporting QC microbiology activities in biologics manufacturing. Responsibilities include serving as SME for microbiological testing methods, leading investigations, implementing new procedures, ensuring regulatory compliance, authoring SOPs, and supporting audit readiness. The role involves data analysis, process improvements, and cross-functional collaboration to optimize laboratory performance. Qualifications: BS/BA in Microbiology, Biology, or related field; 2+ years of relevant microbiology experience; proficiency with LIMS, laboratory software, and data systems; strong analytical and technical writing skills. Preferred: experience supporting regulatory inspections, biologics, sterile manufacturing, gene therapy, and implementing new methods or systems. High-value: microbiology methods (endotoxin, sterility, bioburden, environmental monitoring), cGMP compliance, investigation management, microbiological assay development, and regulatory documentation. Work setup: onsite in Rensselaer, NY, Monday–Friday, 8:00am–4:30pm, with a focus on operational excellence, compliance, and continuous improvement.