The Quality Assurance Document Control Specialist role is a position with responsibilities for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and document issuance and reconciliation.
What can you expect?
- Responsible for managing the document control systems and processes for the site.
- Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures.
- Support Document Management system users with workflow handling and electronic system usage.
- Manage the periodic review process for procedures.
- Issuance of batch related documentation in support of GMP manufacturing.
- Reconcile GMP documentation following document lifecycle requirements.
- Creation and issuance of GMP logbooks.
- Responsible for storage and archival of GMP documents and batch related records.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Review and approve SOPs, and other documentation.
- Drive continuous improvement.
- Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
Who are we looking for?
Education:
- You are an undergrad, have a secondary degree or equivalent through experience.
Experience:
- Not required.
- It is preferable that the candidate has experience working in a GMP environment, but this is not a must.
Language:
- Dutch and technical English
Strengths:
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Strong written and verbal communication skills
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Strong analytical problem‑solving and conflict‑resolution skills
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Highly organized, detail‑oriented, and able to multitask effectively
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Ability to manage shifting priorities and meet critical deadlines in a fast‑paced, dynamic environment
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Flexible and highly motivated, including flexibility in work schedule
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Effective interpersonal skills with the ability to communicate across all levels of the organization
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Ability to work independently with a high degree of accountability
Expertise:
- GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11 / Annex 11, PIC/S, MHRA)
- Operational experience with electronic quality systems
- Experience with Document Management Systems (e.g. TruVault, Veeva)
- Proficient knowledge of Microsoft Office applications (Outlook, Excel, Word, PowerPoint)
What do we offer you?
- A meaningful job with an excellent work-life balance. You will work 4 days, followed by 4 days at home.
- A supportive and innovative work environment that encourages learning and personal development.
- The opportunity to work with people from all over the world.
- You start working through interim contracts. After 6 months you'll receive a permanent contract.
- An attractive salary package with numerous benefits, including additional statutory vacations, meal vouchers of €7/day , group and hospitalization insurance once you start your permanent contract, double vacation pay, and performance bonuses.
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.
The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).
In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.
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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
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