Document Control Specialist

Legend Biotech is seeking Document Control Specialist as part of the Quality team based in Raritan, NJ.

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.

Shift Schedule: Wed-Sat, 1st Shift

Key Responsibilities

• Print and review In-process, intermediate and final product labels using validated label software and approved templates in accordance with batch records, standard operating procedures (SOPs) and regulatory guidelines.
• Ensure accurate printed information on labels in compliance with SOPs and health authority requirements.
• Confirm that labels meet formatting, content and quality standards before issuance.
• Maintain strict control of label inventory (blank and printed) in accordance with internal procedures.
• Document Issuance, use and reconciliation of all labels to ensure traceability.
• Accurately record label printing and reconciliation activities in forms, logbooks and electronic systems in compliance with GMP documentation standards.
• Support audit and inspections by ensuring traceability and integrity of all labeling activities.
• Perform routine print head cleanings of label printers.
• Operate and troubleshoot label printers (e.g, Zebra printers) as needed.
• Coordinate with Operations teams to ensure timely issuance of labels.
• Performs training in label control and issuance requirements for new hire as needed
• Issuance of batch related documentation and labels in support of GMP manufacturing.
• Reconcile GMP documentation following document lifecycle requirements.
• Creation and issuance of GMP logbooks/notebooks.
• 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.
• Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control, Operations Technical Support, Supply Chain and Planning.

Requirements

• A minimum of a Bachelors 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 a cGMP 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 and troubleshooting with Zebra thermal transfer printers is preferred.
• 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.
• Strong attention to detail and ability to follow SOPs with minimum supervision.
• 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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