QA Document Control Specialist

Introduction

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.

Would you like to participate in personalized cell therapy that is unique and progressive? If so, we would love to help you. We are proud to partner with our client who is committed to innovations in cell therapy, oncology and immune cell biology and engineering.

• 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.

• 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.

You will have the opportunity to help make a difference, grow with the company.

• Degree in Science, Information Science, Communication or equivalent technical discipline is required.
• Experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
• 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 in Dutch and English, 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).