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
Profile
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)
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
Language Requirements: Dutch and Technical English