QC Bioassay Analyst (2nd shift)

Title: QC Specialist – BioassayLocation: Greater Norwood Area, MA (Onsite)Shift: 2PM-10PM M-FEmployment Type: ContractStatus: Accepting CandidatesAbout the roleSupport cGMP QC bioassay testing across raw materials, drug substance, and finished products in a manufacturing environment. This role partners cross-functionally with QA, Manufacturing, and Development while contributing to method transfers and lab expansion activities.Key ResponsibilitiesExecute and troubleshoot cell-based bioassays, ELISA, and protein analysisSupport method transfer, validation, and qualification activitiesOwn and manage quality records (CAPA, deviations, change controls, investigations)Write/revise SOPs, protocols, and technical reportsPerform aseptic techniques and routine lab operations in a cGMP environmentTrain analysts and collaborate across QA, Manufacturing, and Development teamsQualificationsBA/BS degree with 2+ years in a cGMP laboratoryHands-on experience with mammalian cell culture and cell-based assaysStrong experience in ELISA and protein analysisExperience with method validation/qualificationKnowledge of FDA, EU, ICH guidelines and GMP documentationExperience with technical writing and trainingCompensation (MA Pay Transparency):Estimated hourly range: $30–$40/hr (W-2)Final rate within this range will be based on skills, experience, and interview results.