QA Shop Floor Specialist II
Legend Biotech
4 days ago
On-site
Raritan, NJ
Operations
QA Shop Floor Specialist (Quality Operations) — Raritan, NJ
Schedule: Wed–Sat, 1st shift
Role Overview
Exempt role providing floor quality oversight for production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom, ensuring compliance with company procedures and applicable regulations.
Key Responsibilities
- Provide QA oversight of cell therapy clinical manufacturing.
- Support cGMP compliance via spot checks/internal audits.
- Collaborate with site personnel to resolve manufacturing quality issues.
- Review all documentation per Good Documentation Practices (GDP).
- Review, revise, or draft SOPs.
- Support aseptic process simulations and manufacturing/sterility assurance activities.
- Support batch review & material release in SAP for in-house reagents.
- Support floor spot-checks and audit trail review; drive reduction of non-conformances.
- Provide quality/compliance input for investigations, continuous improvement, and remediations.
- Backup for approving printed labels/documents before use on the manufacturing floor.
- Use electronic quality systems, batch records, and SAP; work cross-functionally.
- Support regulatory inspections/audits as needed; adhere to safety, quality, and cGMP requirements.
Requirements (Required/Preferred)
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years biotech/pharma experience.
- Relevant experience in an aseptic manufacturing facility (prefer QA, manufacturing compliance, clinical quality, technical operations, or cell therapy).
- Preferred: quality support in clinical manufacture.
- Strong SAP, electronic batch records (EBR), and quality systems proficiency; MS Office.
- Knowledge of cGMP and FDA/EU guidance for cell-based products; Good Tissue Practices.
- Ability to aseptically gown and practice aseptic behavior (ISO 5/BSC); lift up to 20 lbs; on-site onsite work; weekend flexibility as needed.
Benefits
Medical/dental/vision; 401(k) match (vests day one); 8 weeks paid parental leave after 3 months; PTO (vacation/personal/sick/floating holidays) and 11 company holidays; additional voluntary benefits (e.g., HSA/FSA, life/AD&D, disability, legal assistance, supplemental plans).
Schedule: Wed–Sat, 1st shift
Role Overview
Exempt role providing floor quality oversight for production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom, ensuring compliance with company procedures and applicable regulations.
Key Responsibilities
- Provide QA oversight of cell therapy clinical manufacturing.
- Support cGMP compliance via spot checks/internal audits.
- Collaborate with site personnel to resolve manufacturing quality issues.
- Review all documentation per Good Documentation Practices (GDP).
- Review, revise, or draft SOPs.
- Support aseptic process simulations and manufacturing/sterility assurance activities.
- Support batch review & material release in SAP for in-house reagents.
- Support floor spot-checks and audit trail review; drive reduction of non-conformances.
- Provide quality/compliance input for investigations, continuous improvement, and remediations.
- Backup for approving printed labels/documents before use on the manufacturing floor.
- Use electronic quality systems, batch records, and SAP; work cross-functionally.
- Support regulatory inspections/audits as needed; adhere to safety, quality, and cGMP requirements.
Requirements (Required/Preferred)
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years biotech/pharma experience.
- Relevant experience in an aseptic manufacturing facility (prefer QA, manufacturing compliance, clinical quality, technical operations, or cell therapy).
- Preferred: quality support in clinical manufacture.
- Strong SAP, electronic batch records (EBR), and quality systems proficiency; MS Office.
- Knowledge of cGMP and FDA/EU guidance for cell-based products; Good Tissue Practices.
- Ability to aseptically gown and practice aseptic behavior (ISO 5/BSC); lift up to 20 lbs; on-site onsite work; weekend flexibility as needed.
Benefits
Medical/dental/vision; 401(k) match (vests day one); 8 weeks paid parental leave after 3 months; PTO (vacation/personal/sick/floating holidays) and 11 company holidays; additional voluntary benefits (e.g., HSA/FSA, life/AD&D, disability, legal assistance, supplemental plans).