Qc Sample Coordinator

il y a 3 semaines

Gent, Belgique Legend Biotech Temps plein

**Company Information**

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). 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.

**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 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 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

**Legend Core Behaviors**

Ownership and Commitment
- Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
- Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
- Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.

Agility and Prioritization
- Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
- Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
- Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
- Employs good project management principles to appropriately align time, resources, and budgets.

Teamwork and Communication
- Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
- Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
- Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
- Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.

Continuous Improvement
- Actively pursues and shares knowledge, builds skills, promotes new ideas and embraces change.
- Generates new solutions to problems by challenging the status quo and conventional thinking.

Legend Biotech maintains a drug-free workplace.

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