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    Qc Data Reviewer

    Legend Biotech Us
    1+ years
    Not Disclosed
    Raritan
    10 July 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position Information:

    • Employer: Legend Biotech USA, Inc.
    • Category: QC
    • Location:
      • Country: United States
      • State: New Jersey (NJ)
      • City: Raritan
    • Post Date: 05/16/2024

    Company Information:

    Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across diverse technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

    In 2017, Legend Biotech entered into a global collaboration agreement with Janssen, one of Johnson & Johnson's pharmaceutical companies, to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel). This strategic partnership combines the strengths and expertise of both companies to advance immunotherapy in the treatment of multiple myeloma.

    Legend Biotech is seeking a QC Data Reviewer to join the Quality team 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 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, SOPs, and WIs.
    • Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
    • Immediately alert supervisor/manager when data discrepancies are identified.
    • Occasionally handle biological materials and hazardous chemicals.

    Requirements:

    • Education: Bachelor's degree in science, Engineering, or equivalent technical discipline.

    • Experience: Minimum of 1-year relevant work experience, preferably within a biological and/or pharmaceutical industry.

    • Skills:

      • Experience in a Quality Control setting preferred.
      • Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacturing of cell-based products.
      • Detailed knowledge of CAR-T QC test methods and related equipment preferred.
      • Excellent written and oral communication skills.
      • Highly organized and capable of working in a team environment with a positive attitude under some supervision.
      • Comfortable speaking and interacting with inspectors.

    • Availability:

      • Accommodate shift schedules, including routine weekend and evening work as required by the manufacturing process.
      • Accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
      • 100% onsite at the Raritan, NJ location.

    Additional Information:

    Legend Biotech 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.

    Legend Biotech maintains a drug-free workplace.

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