QA Document Control Specialist

Role Overview: 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. 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. QualificationsEducation:

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. 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. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). What do we offer?A meaningful job with an excellent work-life balance. You will work 4 days (10 hours/day).

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. Language RequirementsDutch and technical EnglishLegend 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.