Legend Biotech
QA, Shop Floor Specialist II
$78K–$103K
Raritan, New Jersey, United States · Full-time · Posted Jul 14, 2026
- Experience
- 0-2+ years 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; the employer participates in E-Verify.
About the job
Provides on-site quality assurance oversight for clinical and commercial CAR-T manufacturing in a cGMP cleanroom, supporting compliance, documentation, and manufacturing quality issues.
What you'll do
- Oversee cell therapy manufacturing quality, including audits, spot checks, documentation review, and cGMP compliance.
- Support batch review and material release, SOPs, investigations, and manufacturing quality issue resolution.
- Support regulatory inspections and audits and maintain aseptic practices in controlled cleanroom areas.
What they ask for
- Bachelor’s degree in Life Sciences or Engineering.
- 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience.
- Relevant working experience in an aseptic manufacturing facility.
- Knowledge of cGMP regulations and FDA/EU guidance related to cell-based product manufacturing, and Good Tissue Practices.
Nice to have
- Quality support experience in clinical manufacture.
- Experience in quality assurance, manufacturing compliance, clinical quality, technical operations, or cell therapy.
Pay
$78,251 — $102,705 USD (base salary)
Tools
SAP, electronic batch records (EBR), MS Office
Model-written summary · the original posting is authoritative