Legend Biotech
QA, Shop Floor Specialist II
$78K–$103K
Raritan, New Jersey, United States · Full-time · Posted Sep 2, 2026
- Experience
- 0–2+ years of biotech/pharmaceutical experience or equivalent industry experience.
- Education
- Bachelor’s degree in Life Sciences or Engineering.
- Visa sponsorship
- Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.
About the job
Provides quality oversight on the manufacturing floor for clinical and commercial autologous CAR-T products in a cGMP cleanroom, ensuring compliant production and documentation.
What you'll do
- Oversee cell therapy manufacturing quality, perform spot checks and audits, and guide teams in addressing manufacturing quality issues.
- Review manufacturing documentation and SOPs; support batch review, material release, investigations, and regulatory inspections.
- Promote cGMP compliance and sterility while supporting manufacturing activities in controlled cleanroom environments.
What they ask for
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years of biotech/pharmaceutical experience or equivalent industry experience.
- Relevant working experience in an aseptic manufacturing facility.
- Knowledge of cGMP regulations and FDA/EU guidance for cell-based product manufacturing, and Good Tissue Practices.
Nice to have
- Experience in quality assurance, manufacturing compliance, clinical quality, technical operations, or cell therapy.
- Experience with quality support in clinical manufacturing.
Pay
$78,251 — $102,705 USD (base pay)
Tools
SAP, electronic batch records (EBR), MS Office
Model-written summary · the original posting is authoritative