Quality Control Analyst, II

Role: QC Laboratory Technician performing routine and non-routine assays on raw materials, in-process, drug product, and stability samples for cell therapies in a cGMP environment. Responsibilities: conduct molecular, microbial, environmental, and bioburden testing using instruments like spectrophotometers and pH meters; review data, report out-of-spec results, perform equipment calibration, and support audit readiness; assist with laboratory transfer and documentation updates; participate in troubleshooting, investigations, and training. Requirements: HS diploma with 6+ years’ industry experience in a cGMP lab or equivalent; degree in microbiology, molecular biology, biochemistry, or related field with relevant industry experience; demonstrated proficiency in molecular/biological assays (PCR, flow cytometry). Preferred: 1+ years in cell culture or environmental monitoring; familiarity with microbiological testing, PCR, data management systems (LIMs); biotech/pharma regulated industry experience. HighValue: cell therapies (MACI, Epicel, Nexobrid), regenerative medicine, cGMP, microbial and molecular assays, environmental monitoring, assay development, audit preparation. WorkSetup: onsite in Cambridge and Burlington, MA, transitioning to full Burlington; training in Cambridge; schedule options Sunday–Thursday or Tuesday–Saturday.