Document Control Specialist

Legend Biotech is seeking Document Control Specialist as part of the Quality team based in Raritan, NJ
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The QA Document Control Specialist 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.

Mid-Shift 12-8 PM

• Reconcile GMP documentation following document lifecycle requirements.
• Creation and issuance of GMP logbooks and formbooks.
• 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.
• 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.

• 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.
• Experience with Document Management Systems (Veeva) is preferred.
• Proficient knowledge of Microsoft Office.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

We are committed to creating a workplace where employees can thrive – both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way.

Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national…