QC Investigations Specialist II

Legend Biotech is seeking QC Investigations Specialist (1st and 2nd Shift) as part of the Quality team based in Raritan, NJ. 

Role Overview

The QC Investigations Specialist, CAR-T Manufacturing 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.

Key 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.

Requirements

• Minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required
• Minimum of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required. 
• Minimum of 2 years of Quality Control experience is required.
• Minimum of 2 years of experience with leading investigations is required.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is a plus.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Detailed knowledge of CAR-T QC test methods and related equipment is preferred
• Excellent written and oral communication skill are required
• 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.

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