QA Warehouse Incoming/Raw Material Specialist I

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 a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to be part of the team responsible for Warehouse activities that will include material receipt, incoming inspection and release of materials required for manufacturing and release of patient material/final product of CAR-T at Raritan, NJ Legend manufacturing site.

Key Responsibilities

Be part of the quality team responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment.

Reviews, inspection, and disposition of all incoming materials for use in CAR-T product manufacturing per inspection plan and record results to complete receipt process.

Reviews inspection documentation (C of A or other Material Certifications) for inbound materials.

Conducts routine housekeeping checks of the Warehouse and supporting areas.

Conducts routine reviews of warehouse documents and logbooks to ensure that GDP are being adhered to.

Ensures that all materials are in the proper location and under the appropriate storage conditions.

Make appropriate quality decisions in support of warehouse activities.

Ensure that cycle counts are accurate and performed in a timely manner in accordance with the procedures.

Review and inspect documentation in support of Final Product Shipments.

Generates inspection reports and non-conformances for failures as required.

Scanning, filing and archival of QA related documents.

Assist with receiving, shipping or material handling tasks in a backup role, as needed.

Updates supervisor/manager of work status or problems with recommendations for improvement or correction.

Good decision making and troubleshooting skills in relation to procedures, regulatory standards, and company policies.

Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.

Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.

Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Other duties will be assigned, as necessary.

Key Relationships: Works in a collaborative team setting with quality and operations counterparts that include Manufacturing Operations, Quality Assurance, Engineering and Validation, Quality Control and Warehouse Operations.

Requirements

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.

Minimum of 4 years of experience in Quality Assurance related to manufacturing is required and a minimum of 2 years of experience with quality support in clinical manufacture or NPI is preferred.

Experience in clinical quality, method development, cell banking, or Research & Development is preferred.

Proficient in the use of quality systems such as SAP.

Experience working with cell therapy is preferred

Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required

Knowledge of Good Tissue Practice is required

Excellent written and oral communication skills are required

Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.

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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.