QC Investigations Specialist II

Legend Biotech US • Raritan, NJ

84d • $75,972 - $99,713

About The Position

Legend Biotech is seeking QC Investigations Specialist II as part of the Quality team based in Raritan, NJ. The QC Investigations Specialist is an exempt level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Requirements

• 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 in a Quality Control setting is preferred.
• 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.
• Detailed knowledge of CAR-T QC test methods and related equipment is preferred.
• Excellent written and oral communication skills 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.

Nice To Haves

• 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.

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.

Benefits

• Medical, dental, and vision insurance.
• 401(k)-retirement plan with company match that vest fully on day one.
• Equity and stock options available to employees in eligible roles.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees