QA, Document Control Specialist I

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

Job summary

An established industry player in cell therapy is seeking a QA Document Control Specialist to support document management in a sterile GMP environment. This role is crucial for ensuring compliance and supporting both clinical and commercial requirements. The ideal candidate will have a strong background in quality assurance, excellent communication skills, and experience with electronic quality systems. Join a collaborative team where your contributions will enhance the quality processes and support innovative therapies. This position offers a dynamic work environment with opportunities for professional growth.

Qualifications

• Minimum 2 years experience in quality assurance or manufacturing compliance.
• GxP Quality System knowledge including relevant regulations.

Responsibilities

• Manage document control processes for GMP manufacturing.
• Review and approve SOPs and other documentation.

Skills

Document Management

Quality Assurance

Analytical Problem Solving

Communication Skills

Microsoft Office

Education

Bachelor's Degree in Science

Information Science

Tools

TruVault

Veeva

Job description

Legend Biotech is seeking QA, Document Control Specialist (1st Shift) as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Document Control Specialist (1st shift) 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

• 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
• 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 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 guidance (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 knowledge of Microsoft Office
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)

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,"conclusion":"
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.