QA Shop Floor Specialist II
Legend Biotech
August 07, 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 operations in a controlled cGMP cleanroom environment, ensuring compliance with company policies, procedures, and applicable regulations.
Schedule: Wed–Sat, 1st Shift
Key Responsibilities
- Provide quality oversight of the cell therapy clinical manufacturing process.
- Support cGMP compliance via spot checks/internal audits.
- Collaborate with site personnel to guide immediate action for manufacturing quality issues.
- Review all documentation per Good Documentation Practices (GDP).
- Review, revise, or draft SOPs.
- Support aseptic process simulations and manufacturing runs to ensure sterility is not compromised.
- Support batch review & material release in SAP for in-house reagents.
- Support floor spot-checks/audit trail reviews.
- Reduce non-conformances by proactively driving compliance.
- Provide quality/compliance input to Investigations for continuous improvement and remediations.
- Serve as backup for approving printed labels/documents prior to use.
- Use electronic quality systems, batch records, and SAP; work cross-functionally.
- Aseptically gown and provide QA shop floor support for extended periods.
- Support regulatory inspections/audits as needed.
Requirements
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years biotech/pharma experience (or equivalent).
- Aseptic manufacturing facility experience (preferably QA, manufacturing compliance, clinical quality, technical operations, or cell therapy).
- Strong proficiency with SAP, electronic batch records (EBR), and quality systems.
- Knowledge of cGMP regulations and FDA/EU guidance for cell-based products; Good Tissue Practices knowledge preferred.
- Ability to work weekends as needed; on-site attendance required.
- Ability to lift 20 lbs; able to stand/walk/climb/bend/stoop/reach; mobile between sites.
Benefits (as stated)
- Medical/dental/vision; 401(k) with match (vests day one).
- 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays) and 11 company holidays.
Pay Range (as stated)
- Base pay: $96,267–$126,351 USD.
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 operations in a controlled cGMP cleanroom environment, ensuring compliance with company policies, procedures, and applicable regulations.
Schedule: Wed–Sat, 1st Shift
Key Responsibilities
- Provide quality oversight of the cell therapy clinical manufacturing process.
- Support cGMP compliance via spot checks/internal audits.
- Collaborate with site personnel to guide immediate action for manufacturing quality issues.
- Review all documentation per Good Documentation Practices (GDP).
- Review, revise, or draft SOPs.
- Support aseptic process simulations and manufacturing runs to ensure sterility is not compromised.
- Support batch review & material release in SAP for in-house reagents.
- Support floor spot-checks/audit trail reviews.
- Reduce non-conformances by proactively driving compliance.
- Provide quality/compliance input to Investigations for continuous improvement and remediations.
- Serve as backup for approving printed labels/documents prior to use.
- Use electronic quality systems, batch records, and SAP; work cross-functionally.
- Aseptically gown and provide QA shop floor support for extended periods.
- Support regulatory inspections/audits as needed.
Requirements
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years biotech/pharma experience (or equivalent).
- Aseptic manufacturing facility experience (preferably QA, manufacturing compliance, clinical quality, technical operations, or cell therapy).
- Strong proficiency with SAP, electronic batch records (EBR), and quality systems.
- Knowledge of cGMP regulations and FDA/EU guidance for cell-based products; Good Tissue Practices knowledge preferred.
- Ability to work weekends as needed; on-site attendance required.
- Ability to lift 20 lbs; able to stand/walk/climb/bend/stoop/reach; mobile between sites.
Benefits (as stated)
- Medical/dental/vision; 401(k) with match (vests day one).
- 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays) and 11 company holidays.
Pay Range (as stated)
- Base pay: $96,267–$126,351 USD.