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QC Sample Coordinator

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Astrid Matthys
Recruiter



Astrid Matthys
Recruiter
+32476068376


Description de l'emploi

The company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. We are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.  

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
  • 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

Profil

  • 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)
  • 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 Ghent and may require up to 5% of travel
  • This position will occasionally require to lift up to 10 kg

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Formation et expérience

Nombre d'années d'expérience*
+32476068376