QA Laboratory Compliance Specialist III
Legend Biotech
June 26, 2026
On-site
Raritan, NJ
Operations
Role Overview:
QA Lab Compliance (QALC) Specialist III (exempt). Provide quality and compliance oversight for Quality Control laboratories testing advanced therapy products; collaborate with QC Release, QC IPL, QC Micro, QC Lab Services, and QC Investigations.
Key Responsibilities:
- Collaborate with QC functional areas to provide QA oversight.
- Attend 1/1 meetings with QA supervisors; train/coach Level I/II QALC.
- Provide oversight for QC laboratories to ensure quality, compliance, and adherence to global standards and regulatory requirements.
- Oversee spot-checks; perform ad-hoc QC lab walk-throughs to ensure GMP is followed.
- Conduct formbook reviews, UARs, SOP reviews, quarterly trend reports, and spot checks; drive closure of identified trends.
- Reduce non-conformances by proactively driving compliance.
- Serve as SME for QA topics supporting QC lab activities.
- Support regulatory inspections/audits by ensuring QC areas are audit-ready.
QC Investigations:
- Provide QA insight for complex investigations with root cause, corrections, and CAPAs.
- Monitor investigation lifecycle/timelines; ensure CAPAs are in place.
- Track record closure timelines/metrics; perform escalations of potential significant nonconformances.
- Provide quality oversight on checkpoint/Rapid Response calls and present investigation status for audits.
Requirements:
- Bachelor’s degree in Science or equivalent; 2+ years relevant experience; 1+ year in QA.
- Strong knowledge of Nonconformance/CAPA; cGMP/cGLP and FDA/EU GMP guidance; familiarity with cell-based products/CAR-T.
- Strong communication; ability to interpret complex issues and make critical decisions; attention to detail.
- Experience reviewing GMP documentation (SOPs, work instructions, investigations, CAPAs, change controls); Microsoft Office.
- On-site, required full week.
Benefits:
Medical/dental/vision, 401(k) with match (vests day one); 8 weeks paid parental leave after 3 months; PTO including vacation/personal/sick/floating holidays; 11 company holidays; performance bonus/equity (eligible roles).
QA Lab Compliance (QALC) Specialist III (exempt). Provide quality and compliance oversight for Quality Control laboratories testing advanced therapy products; collaborate with QC Release, QC IPL, QC Micro, QC Lab Services, and QC Investigations.
Key Responsibilities:
- Collaborate with QC functional areas to provide QA oversight.
- Attend 1/1 meetings with QA supervisors; train/coach Level I/II QALC.
- Provide oversight for QC laboratories to ensure quality, compliance, and adherence to global standards and regulatory requirements.
- Oversee spot-checks; perform ad-hoc QC lab walk-throughs to ensure GMP is followed.
- Conduct formbook reviews, UARs, SOP reviews, quarterly trend reports, and spot checks; drive closure of identified trends.
- Reduce non-conformances by proactively driving compliance.
- Serve as SME for QA topics supporting QC lab activities.
- Support regulatory inspections/audits by ensuring QC areas are audit-ready.
QC Investigations:
- Provide QA insight for complex investigations with root cause, corrections, and CAPAs.
- Monitor investigation lifecycle/timelines; ensure CAPAs are in place.
- Track record closure timelines/metrics; perform escalations of potential significant nonconformances.
- Provide quality oversight on checkpoint/Rapid Response calls and present investigation status for audits.
Requirements:
- Bachelor’s degree in Science or equivalent; 2+ years relevant experience; 1+ year in QA.
- Strong knowledge of Nonconformance/CAPA; cGMP/cGLP and FDA/EU GMP guidance; familiarity with cell-based products/CAR-T.
- Strong communication; ability to interpret complex issues and make critical decisions; attention to detail.
- Experience reviewing GMP documentation (SOPs, work instructions, investigations, CAPAs, change controls); Microsoft Office.
- On-site, required full week.
Benefits:
Medical/dental/vision, 401(k) with match (vests day one); 8 weeks paid parental leave after 3 months; PTO including vacation/personal/sick/floating holidays; 11 company holidays; performance bonus/equity (eligible roles).