Cell Therapy Quality Assurance Specialist

9 hours ago


Raritan, New Jersey, United States Legend Biotech US Full time
Job Title: QC Data Reviewer

Legend Biotech US is seeking a highly skilled QC Data Reviewer to join our Quality team based in Raritan, NJ.

Job Summary

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 eLIMS Electronic Notebooks, laboratory formbooks, training formbooks, instrument logbooks, and records.
  • Utilize 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 alert supervisor/manager when data discrepancies are identified.
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 skills are required.
  • Candidates must be able to accommodate shift schedule, including 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.

Legend Biotech US is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.



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