Senior Specialist, QC Analytical, Cell Therapy

Position Summary Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts. Duties/Responsibilities Perform method transfer/validation and routine testing of in-process, final product, and stability samples. Anticipate and perform routine troubleshooting and problem solving with minimal guidance. Perform data verification, data review, and review of GMP documentation for general and complex methods. Perform document revision, project, CAPA, and deviation/investigation related tasks and/or continuous improvement efforts. Train and mentor others on QC test methods, processes, and procedures. Perform other tasks as assigned. Qualifications Specific Knowledge, Skills, Abilities Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements. Demonstrated technical writing skills. High problem‑solving ability; technically adept and logical. Ability to communicate effectively with peers, department management, and cross‑functional peers. Ability to work in a fast‑paced team environment, meet deadlines, and prioritize work. Advanced knowledge of LIMS and ELN and laboratory data analysis systems preferred. Education/Experience Bachelor’s degree or equivalent required (preferably in science). 4+ years of relevant analytical testing or QC experience (preferably in a regulated environment). Demonstrated experience in cell and molecular biology techniques (e.g., cell‑based assays, flow cytometry, qPCR, ELISA, aseptic technique). Compensation Overview (Devens, MA) $43.84–$53.12 per hour (starting range). Additional incentive cash/stock may be available (based on eligibility). #J-18808-Ljbffr