Qc Sample Coordinator - Gent, België - Legend Biotech EU

Legend Biotech EU

Geverifieerd bedrijf

Gent, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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.