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QC Specialist, Lab Services
4 months ago
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 QC Specialist, Lab Services - I, II, III as part of the Quality team based in Raritan, NJ.
Role Overview
The QC Specialist, Lab Services, is responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively.
Key Responsibilities
* Prepares and reviews documentation independently.
* Prepares and reviews documentation independently.
* Responsible for QC sample and retain management.
* Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.
* Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS).
* Prepare documents and coordinate Sample shipment (internal and external shipments).
* Review logbooks and/ or LIMs to align physical quantities of samples in freezers/refrigerators.
* Periodic inspection and consolidation of retains.
* Document and perform sample management related non-conformance investigations.
* Document and handle corrective and preventative action records.
* Supports internal and regulatory audits.
Requirements
* A minimum of a Bachelor's degree or higher, a degree in Biology, Biochemistry, Microbiology, Chemistry or related field.
* A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry.
* Solid understanding of regulatory requirements, policies and guidelines.
* Experience with Quality Control document reviews and regulatory inspection processes.
* Working knowledge of Quality systems.
* Experience in management of retain samples using electronic systems (eLIMS).
* Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process.
* This position will be located in Raritan, NJ and may require up to 5% of travel.
* This position will occasionally require to lift up to 20 pounds
#LI-NP
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.
