QC Analyst I/II

Role: QC Analyst responsible for performing quality control testing of cell therapy products, including autologous CAR-T, for clinical trials and commercial manufacturing in a GMP environment. Responsibilities: execute analytical testing of raw materials, in-process, and final products; ensure testing compliance with GMP, SOPs, and relevant regulations; review and approve laboratory data and documentation; collaborate with QA, Manufacturing, and Development teams; work within a controlled cleanroom setting handling biological materials and hazardous chemicals. Requirements: Bachelor's in Science, Engineering, or related field; at least 1 year of relevant experience, preferably in biopharma quality control; knowledge of GMP, biosafety, and cell-based product testing; experience with cGMP labs and aseptic techniques preferred; ability to work in shifts including weekends and respond to unplanned overtime; strong communication, organization, and teamwork skills. High-Value: focus on cell therapy (CAR-T) manufacturing, GMP compliance, QC testing, biological sample processing, and collaboration across QA, manufacturing, and development teams at a commercial and clinical stage in Raritan, NJ, with up to 5% travel.