Sr. Specialist, QC Microbiology (PCR, endotoxin and sterility)
$43.84 - $53.12 per hourScorpion Therapeutics
Job Summary QC Senior Specialist for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. Supports Quality Control microbiology testing for release of clinical and commercial cell therapy drug product, including interfacing with multiple groups, independently performing tasks, interpreting results, troubleshooting, assisting with training and assay transfer. Shift/Days/Hours Sunday to Wednesday, 2:00 p.m. to 12:00 a.m. Job Responsibilities Perform compendial verification, method transfer/validation, and routine testing of in-process, final product, and stability samples. Apply scientific principles and proper lab equipment use for Sterility, Bioburden, Endotoxin, and Environmental monitoring. Anticipate and troubleshoot problems. Train new analysts; become a qualified trainer on assigned assays and document training per procedural and cGMP requirements. Support document revision, project, CAPA, and investigation/deviation tasks; perform assigned tasks within CAPA/deviation/project. May lead projects and continuous improvement efforts. Support QC/manufacturing operations, including possible on-call/shift/weekend coverage. Qualifications Bachelor's degree required (preferably Science). 4+ years relevant experience (preferably regulated environment). Experience in a GMP laboratory (preferably with cell therapy products). Knowledge of aseptic technique. Hands-on microbiology experience incl. PCR, endotoxin, and sterility testing. Ability to follow/apply Global Regulatory and cGMP requirements. Strong technical writing, problem-solving, and communication skills. Ability to represent the group on cross-functional teams. Working knowledge of LIMS and data analysis systems highly desirable. Benefits/Compensation Devens, MA: $43.84-$53.12 per hour (plus potential discretionary incentive cash/stock). Comprehensive benefits (medical, dental, vision, life, disability); FTO (exempt) or vacation/holidays (non-exempt), plus other time-off benefits as eligible. #J-18808-Ljbffr Scorpion Therapeutics
Vacancy posted 12 hours ago
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