Legend Biotech · 12 hours ago
QC Investigations Specialist II
Raritan, NJ
Full-time
Onsite
Mid Level
$76K/yr - $100K/yr
4+ years expLegend Biotech is a global biotechnology company focused on developing advanced cell therapies for life-threatening diseases. The QC Investigations Specialist II will lead deviations and corrective actions in support of QC testing laboratories related to cell therapy products, ensuring compliance with GMP standards.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise
Review/complete routine CAR-T manufacturing nonconformance/deviation investigations
Proactively work with stakeholders to implement effective CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories
Provide recommendations for the improvement of processes by working cross functionally with multiple stakeholders
Work closely with management to propose/execute improvements through the change management system
Ability to respond with a high degree of urgency to departmental and cross functional needs and requests
Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA)
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development
Qualification
Required
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
A Minimum of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required
Knowledge of Good Tissue Practices is required
Excellent written and oral communication skill are required
Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process
Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision
Comfortable with speaking and interacting with inspectors
This position may require occasional travel to partner sites in NJ or PA as business demands
This position may require up to 10% domestic or international travel as business demands
Preferred
Experience in a Quality Control setting is preferred
Detailed knowledge of CAR-T QC test methods and related equipment is preferred
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase