QA, Shop Floor Specialist II

Role: QA Shop Floor Specialist overseeing quality assurance for autologous CAR-T manufacturing in a cGMP cleanroom environment. Responsibilities include providing quality oversight of clinical manufacturing processes, conducting spot checks and audits, reviewing documentation (GDP-compliant), supporting aseptic process simulations, batch review, and material release, and assisting investigations for continuous improvement. The role requires ensuring compliance with all relevant regulations, supporting regulatory inspections, and maintaining high standards of cleanliness and sterility. Qualifications: Bachelor’s degree in Life Sciences or Engineering; 0-2+ years of biotech/pharma experience, preferably in aseptic manufacturing, quality assurance, or cell therapy. Must have experience working in a GMP environment and knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices. Technical skills include proficiency with SAP, electronic batch records, and quality systems. The role demands strong attention to detail, communication skills, and the ability to work in a team-oriented, fast-paced setting. Must be able to aseptically gown, lift 20 lbs, and work on-site in Raritan, NJ, with flexibility for weekend work and site transport. The position involves exposure to biological materials and hazardous chemicals, requiring compliance with safety standards. It is suited for individuals with a background in clinical or manufacturing quality support within cell therapy or biopharma manufacturing.