QA Document Control Specialist

il y a 2 semaines

Gent, Belgique Legend Biotech US 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 Quality Assurance Document Control Specialist role is an exempt level 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.

**Major Responsibilities**:

- 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.

**Qualifications**

**Education**:
A minimum of a Bachelor's Degree in Science, Information Science, Communication or equivalent technical discipline is required.

**Experience**:
**Key Capabilities, Knowledge, and Skills**:

- 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 (TruVault/Veeva) is preferred.
- Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
- Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail.
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Flexibility in work schedule is required.
- Effective interpersonal skills with the ability to communicate across all levels of the organization.
- Ability to work independently with a high degree of accountability.
- Proficient knowledge of Microsoft Office.

**Language Requirements**

Dutch and technical English

LI-AG1

Legend Biotech maintains a drug-free workplace.

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