QA Document Control Specialist II

Legend Biotech is seeking QA 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 position responsible 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 & retention, and document issuance & reconciliation.

Key Responsibilities  

• 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.
• Help increase department's productivity, as well as broadening technical and scientific knowledge.

 Key Relationships:

• 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 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 has experience working in a cGMP manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy.  
• Must be able to work Monday- Friday 1st shift
  
• 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 with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

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