Legend Biotech · 5 days ago
QA Document Control Specialist I/II/III
Raritan, NJ
Full-time
Onsite
Entry, Mid, Senior Level
$71K/yr - $93K/yr
2+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. They are seeking a QA Document Control Specialist I/II/III to support the document management process within a cell therapy manufacturing facility, ensuring compliance with GMP requirements and managing documentation effectively.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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
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
Qualification
Required
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 guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA)
Operational experience with electronic quality systems
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
Preferred
Experience with Document Management Systems (TruVault/Veeva)
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase