Document Imaging Supervisor jobs in Somerset, NJ

Legend Biotech is seeking QA Document Control Supervisor as part of the Quality team based in Location. 

Role Overview

The QA Document Control Supervisor 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.

Key Responsibilities  

• Day to day management of resources, planning and assigning work to Document Control Specialists to meet goals and deadlines.
• Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures.
• Ability to manage multiple and complex projects, provide status reports, and coordinate with cross-functional departments.
• Support Document Management system users with workflow handling and electronic system usage.
• Manage the periodic review process for procedures.
• Issue batch related documentation and labels in support of GMP manufacturing.
• Reconcile GMP documentation following document lifecycle requirements.
• Create and issue 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.
• Drive continuous improvement.
• Have advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge.

Requirements

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
• A minimum of 2 years relevant work experience is required. It is preferable that the candidate have 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 (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).

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