QC Data Reviewer

Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. 

Role Overview

The QC Data Reviewer is an exempt level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities  

•    Perform peer review/approval of laboratory data including but not limited to eLIMS Electronic Notebooks, laboratory formbooks, training formbooks, instrument logbooks, and records.
•    Utilization of electronic systems (LIMS) for execution and documentation.
•    Create, review, and approve relevant QC documents, SOP’s and WI’s.
•    Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
•    Immediately alerts supervisor/manager when data discrepancies are identified.
•    Job duties performed may occasionally require exposure to and handling of biological materials and hazardous chemicals.

Requirements

•    Bachelor’s degree in science, Engineering or equivalent technical discipline is required.
•    Minimum of 1-year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
•    Experience in a Quality Control setting is preferred.
•    Knowledge of cGMP and GDP 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 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.
•    Due to the nature of the Data Review process, this role is 100% onsite at the Raritan, NJ location.

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