QA Document Control Specialist I/II/III at Legend Biotech

Raritan, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Apr, 26

Salary

92757.0

Posted On

18 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Control, GMP Compliance, Quality Assurance, Analytical Problem Solving, Communication Skills, Organizational Skills, Attention to Detail, Team Collaboration, Document Management Systems, GxP Quality System Knowledge, Technical Knowledge, Workflow Handling, SOP Review, Continuous Improvement, Aseptic Manufacturing Experience, Electronic Quality Systems

Industry

Biotechnology Research

Description

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. Legend Biotech is seeking QA Document Control Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role Overview 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. Schedule: 2nd Shift, Wed-Sat, 2 PM - 12:30 AM 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 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 guidances (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 #Li-BG1 #Li-Onsite The anticipated base pay range is $70,671—$92,757 USD Benefits 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 vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Responsibilities

The QA Document Control Specialist will support the document management process in a cell therapy manufacturing facility, ensuring compliance with GMP requirements. Responsibilities include document issuance, reconciliation, and storage, as well as supporting users of the document management system.