QA, Investigations Lead II/III
Legend Biotech
9 hours ago
On-site
Raritan, NJ
Operations
Role Overview
The QA Investigation Lead (exempt) provides quality oversight and guidance during investigations of events occurring in the production of a personalized cell therapy product in a sterile GMP environment.
Key Responsibilities
- Ensure timely completion of high-quality robust investigations with appropriate root cause(s).
- Ensure appropriate Corrective and Preventative Actions (CAPA’s) are developed and implemented.
- Escalate events to management that may represent significant quality issues or delay investigation closure and product release.
- Support regulatory inspections and audits by ensuring inspection readiness; serve as an SME during inspections/audits as needed.
- Support Quality Operations compliance activities in accordance with Legend standards, procedures, and cGMPs.
- Collaborate with site personnel to guide and determine resolution for end-to-end manufacturing issues.
- Ensure accurate and timely maintenance and review of investigations, CAPAs, change controls, and complaints.
- Perform analysis on quality-indicating data and identify trends.
- Maintain investigation compliance metrics.
- Support investigation process improvement initiatives.
- May require exposure to and handling of biological materials and hazardous chemicals.
Requirements
- Bachelor’s degree in Science, Engineering, or equivalent technical discipline.
- 2–4 years relevant experience; preferably aseptic manufacturing experience (QA, manufacturing compliance, clinical quality, or cell therapy).
- Knowledge of cGMP and GDP regulations and FDA/EU guidance for cell-based products.
- Strong attention to detail; ability to follow procedures.
- Highly organized; positive team-oriented attitude under minimal supervision.
- Excellent communication (verbal, written, presentations) and ability to summarize results.
- Leadership, decision-making, and ability to interpret problems to determine compliant, risk-minimizing resolutions.
Benefits
- Medical, dental, vision insurance; 401(k) with company match.
- 8 weeks paid parental leave after 3 months.
- Paid time off (vacation, personal, sick, floating holidays) and 11 company holidays.
- Other voluntary benefits include flexible spending/HSAs, life/AD&D, short- and long-term disability, legal assistance, and supplemental plans.
Pay Range (Base Pay): $70,671–$99,713 USD
The QA Investigation Lead (exempt) provides quality oversight and guidance during investigations of events occurring in the production of a personalized cell therapy product in a sterile GMP environment.
Key Responsibilities
- Ensure timely completion of high-quality robust investigations with appropriate root cause(s).
- Ensure appropriate Corrective and Preventative Actions (CAPA’s) are developed and implemented.
- Escalate events to management that may represent significant quality issues or delay investigation closure and product release.
- Support regulatory inspections and audits by ensuring inspection readiness; serve as an SME during inspections/audits as needed.
- Support Quality Operations compliance activities in accordance with Legend standards, procedures, and cGMPs.
- Collaborate with site personnel to guide and determine resolution for end-to-end manufacturing issues.
- Ensure accurate and timely maintenance and review of investigations, CAPAs, change controls, and complaints.
- Perform analysis on quality-indicating data and identify trends.
- Maintain investigation compliance metrics.
- Support investigation process improvement initiatives.
- May require exposure to and handling of biological materials and hazardous chemicals.
Requirements
- Bachelor’s degree in Science, Engineering, or equivalent technical discipline.
- 2–4 years relevant experience; preferably aseptic manufacturing experience (QA, manufacturing compliance, clinical quality, or cell therapy).
- Knowledge of cGMP and GDP regulations and FDA/EU guidance for cell-based products.
- Strong attention to detail; ability to follow procedures.
- Highly organized; positive team-oriented attitude under minimal supervision.
- Excellent communication (verbal, written, presentations) and ability to summarize results.
- Leadership, decision-making, and ability to interpret problems to determine compliant, risk-minimizing resolutions.
Benefits
- Medical, dental, vision insurance; 401(k) with company match.
- 8 weeks paid parental leave after 3 months.
- Paid time off (vacation, personal, sick, floating holidays) and 11 company holidays.
- Other voluntary benefits include flexible spending/HSAs, life/AD&D, short- and long-term disability, legal assistance, and supplemental plans.
Pay Range (Base Pay): $70,671–$99,713 USD