QA, Shop Floor Specialist II

Role: QA Shop Floor Specialist overseeing quality assurance in the cGMP cleanroom production of autologous CAR-T cells for clinical trials and commercial use. Responsibilities: conduct quality oversight, perform audits, review documentation and SOPs, support aseptic process validation and batch release, and assist with investigations to ensure compliance with cGMP, FDA, and EU regulations. Qualifications: Bachelor’s degree in Life Sciences or Engineering; 0-2+ years biotech/pharmaceutical experience, preferably in aseptic manufacturing, quality assurance, or cell therapy. High-Value: cell therapy (CAR-T), autologous products, clinical and commercial manufacturing, cGMP compliance, FDA/EU regulatory knowledge, experience with electronic quality systems (SAP, EBR). WorkSetup: on-site at Raritan, NJ; flexibility to work weekends, with physical ability to perform tasks in controlled environments.