Hiring: QC Analyst I/II Company: BioSpace Location: Raritan, NJ Job Posted Time: 2026-09-11 12:53:52 Employment Type: Full-time Target Skills & Keywords : Project Management, Quality Assurance About the job Experience: •1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required. Required Skills: •The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. •Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. •Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations. •Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories. •Perform peer review/approval of laboratory data. •Utilize electronic systems (LIMS) for execution and documentation of testing. •Create, review and approve relevant QC documents, SOP’s and WI’s. •Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Qualifications: •Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required. •Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required. •Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred. •Knowledge of Good Tissue Practices is required. •Knowledge of CAR-T QC test methods and related equipment is preferred. •Excellent written and oral communication skill are required. •Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process. •Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice. •The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. •Comfortable with speaking and interacting with regulatory inspectors. Compensation: •$68,045 - $89,308 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!