Legend Biotech · 6 hours ago
Document Control Specialist
Raritan, NJ
Full-time
Onsite
Entry, Mid Level
$66K/yr - $87K/yr
2+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Document Control Specialist will support the document management process within a cell therapy manufacturing facility, ensuring compliance and traceability in a sterile GMP environment.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Print and review In-process, intermediate and final product labels using validated label software and approved templates in accordance with batch records, standard operating procedures (SOPs) and regulatory guidelines
Ensure accurate printed information on labels in compliance with SOPs and health authority requirements
Confirm that labels meet formatting, content and quality standards before issuance
Maintain strict control of label inventory (blank and printed) in accordance with internal procedures
Document Issuance, use and reconciliation of all labels to ensure traceability
Accurately record label printing and reconciliation activities in forms, logbooks and electronic systems in compliance with GMP documentation standards
Support audit and inspections by ensuring traceability and integrity of all labeling activities
Perform routine print head cleanings of label printers
Operate and troubleshoot label printers (e.g, Zebra printers) as needed
Coordinate with Operations teams to ensure timely issuance of labels
Performs training in label control and issuance requirements for new hire as needed
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
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 a cGMP 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
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
Strong attention to detail and ability to follow SOPs with minimum supervision
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)
Preferred
Experience and troubleshooting with Zebra thermal transfer printers is preferred
Experience with Document Management Systems (TruVault/Veeva) is preferred
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
legacy.thefly.com
2026-01-22
2026-01-22
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