QA, Document Control Specialist III

Legend Biotech US; Raritan (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is looking for a dedicated QA Document Control Specialist to join its Quality team in a cutting-edge cell therapy manufacturing facility. This role is crucial for maintaining compliance within the document management system while supporting both clinical and commercial operations in a sterile GMP environment. You will be responsible for the issuance and reconciliation of GMP documentation, ensuring all processes align with safety policies and quality systems. If you thrive in a fast-paced, dynamic environment and have a passion for quality assurance, this opportunity is perfect for you.

Qualifications

• 2+ years of experience in quality assurance or cGMP manufacturing.
• Strong knowledge of GxP Quality Systems and relevant regulations.

Responsibilities

• Manage document issuance and reconciliation for GMP manufacturing.
• Ensure compliance with document management processes in a sterile environment.

Skills

Analytical Problem Solving

Conflict Resolution

Written Communication

Verbal Communication

Organization Skills

Attention to Detail

Flexibility

Education

Bachelor’s Degree in Science

Bachelor’s Degree in Information Science

Tools

Document Management Systems (TruVault/Veeva)

Microsoft Office (Outlook, Excel, Word, PowerPoint)

Electronic Quality Systems

Job description

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.
• 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).