QA Document Control Specialist I/II/III

BioSpace; Raritan (NJ); On-site; USD 70,671 - 92,757; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Flexible spending accounts

Paid parental leave

Equity and stock options

Job summary

A leading biotechnology firm in Raritan, New Jersey, is seeking a QA Document Control Specialist to support the document management process within its manufacturing facility. The ideal candidate will have a Bachelor's degree in a related field and at least 2 years of experience in quality assurance or aseptic manufacturing. This position offers a competitive salary and comprehensive benefits package including medical, dental, and paid time off.

Qualifications

• Minimum 2 years of relevant work experience in quality assurance or aseptic manufacturing.
• Knowledge of regulations such as 21 CFR and ICH Q10.
• Operational experience with electronic quality systems.

Responsibilities

• Serve as a Document Control reviewer for procedures and documents.
• Support document management system users with workflow handling.
• Manage storage and archival of GMP documents.
• Review and approve SOPs and other documentation.

Skills

Understanding of GxP quality systems

Strong written and verbal communication

Analytical and problem-solving

Organizational skills

Ability to multi-task

Education

Bachelor’s degree in Science or related field

Tools

TruVault/Veeva Document Management Systems

Job description

QA Document Control Specialist I/II/III

Legend Biotech is a global biotechnology company dedicated to treating life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across multiple technology platforms.

Role Overview

The QA Document Control Specialist is an exempt level position responsible for supporting the document management process within a cell therapy manufacturing facility. In a sterile GMP environment, the position ensures compliance with 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.
• Issue batch‑related documentation in support of GMP manufacturing.
• Reconcile GMP documentation following document lifecycle requirements.
• Create and issue GMP logbooks.
• Manage storage and archival of GMP documents and batch‑related records.
• Perform tasks in a manner consistent with safety policies, quality systems and cGMP requirements.
• Review and approve SOPs and other documentation.
• Drive continuous improvement.
• Apply advanced computer skills to increase department productivity and broaden technical knowledge.
• Collaborate with quality counterparts in Manufacturing Operations, Engineering, Validation, Quality Control, Operations Technical Support, Supply Chain and Planning.

Requirements

• Minimum of a Bachelor’s degree in Science, Information Science or a related technical discipline.
• Minimum of 2 years relevant work experience, preferably in an aseptic manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of GxP quality systems and relevant regulations (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) preferred.
• Strong written and verbal communication skills and analytical/problem‑solving abilities.
• Flexible, highly motivated, strong organization skills, and ability to multi‑task with attention to detail.

Base Pay

$70,671 – $92,757 USD

Benefits

Legend Biotech offers a best‑in‑class benefits package that includes medical, dental, vision, 401(k) with company match, equity and stock options, paid parental leave, paid time off (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, 3 floating holidays), flexible spending and health savings accounts, life and AD&D insurance, disability coverage, legal assistance, supplemental plans, commuter benefits, family planning resources, and well‑being initiatives.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, age, disability, national origin, marital status, genetic information, citizenship status, veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause. Legend may adjust base salary or other discretionary compensation at any time based on individual performance, team, or market conditions. Legend maintains a drug‑free workplace.