QA, Shop Floor Specialist I/II
Legend Biotech
August 29, 2026
On-site
Raritan, NJ
Operations
Role Overview
The QA Shop Floor Specialist is an exempt position responsible for floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment, ensuring compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
- Support cGMP compliance via spot checks/internal audits.
- Collaborate with site personnel to guide immediate paths forward for manufacturing quality issues.
- Review all documentation per Good Documentation Practices (GDP).
- Review, revise, or draft SOPs.
- Support aseptic process simulations and commercial/clinical manufacturing runs to ensure sterility is not compromised.
- Support batch review & material release in SAP for in-house reagents.
- Support floor spot-check and audit trail review; reduce non-conformances through proactive compliance.
- Provide quality/compliance input for investigations, continuous improvement, and remediations.
- Backup for approving printed labels and documents prior to use.
- Utilize electronic quality systems, batch records, and SAP.
- Support regulatory inspections and audits as needed.
Requirements
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years biotech/pharmaceutical experience (or equivalent).
- Relevant experience in an aseptic manufacturing facility (preferably QA, manufacturing compliance, clinical quality, technical operations, or cell therapy).
- Experience supporting quality in clinical manufacturing preferred.
- Flexible for weekend work as needed; on-site at manufacturing facility.
- Must be able to aseptically gown to Grade B clean rooms / practice aseptic behavior.
- Proficiency with SAP, electronic batch records (EBR), quality systems; MS Office.
- Knowledge of cGMP regulations, FDA/EU guidance for cell-based products; Good Tissue Practices.
Benefits (as stated)
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays); other voluntary benefits.
Pay Range (as stated)
- $68,045–$95,540 base pay.
Application Instructions
- Applicants must be authorized to work in the United States (E-Verify; Form I-9 required upon selection).
The QA Shop Floor Specialist is an exempt position responsible for floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment, ensuring compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
- Support cGMP compliance via spot checks/internal audits.
- Collaborate with site personnel to guide immediate paths forward for manufacturing quality issues.
- Review all documentation per Good Documentation Practices (GDP).
- Review, revise, or draft SOPs.
- Support aseptic process simulations and commercial/clinical manufacturing runs to ensure sterility is not compromised.
- Support batch review & material release in SAP for in-house reagents.
- Support floor spot-check and audit trail review; reduce non-conformances through proactive compliance.
- Provide quality/compliance input for investigations, continuous improvement, and remediations.
- Backup for approving printed labels and documents prior to use.
- Utilize electronic quality systems, batch records, and SAP.
- Support regulatory inspections and audits as needed.
Requirements
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years biotech/pharmaceutical experience (or equivalent).
- Relevant experience in an aseptic manufacturing facility (preferably QA, manufacturing compliance, clinical quality, technical operations, or cell therapy).
- Experience supporting quality in clinical manufacturing preferred.
- Flexible for weekend work as needed; on-site at manufacturing facility.
- Must be able to aseptically gown to Grade B clean rooms / practice aseptic behavior.
- Proficiency with SAP, electronic batch records (EBR), quality systems; MS Office.
- Knowledge of cGMP regulations, FDA/EU guidance for cell-based products; Good Tissue Practices.
Benefits (as stated)
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays); other voluntary benefits.
Pay Range (as stated)
- $68,045–$95,540 base pay.
Application Instructions
- Applicants must be authorized to work in the United States (E-Verify; Form I-9 required upon selection).