Qc Sample Coordinator
il y a 1 semaine
Company Information
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview
The
QC Sample Coordinator, 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.Major Responsibilities
- 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
- 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 nonconformance 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 minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry
- A degree in Biology, Biochemistry, Microbiology, Chemistry or related field
- 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)
- This position will be located in Ghent and may require up to 5% of travel
- This position will occasionally require to lift up to 10 kg
Language Requirements
Dutch and Technical English
LI-AG1
LI-Onsite
Legend Biotech maintains a drug-free workplace.
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