QA, Document Control Specialist

Agrisano Unternehmungen; Raritan (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player in biotechnology is seeking a QA Document Control Specialist to join their Quality team in Raritan, NJ. This vital role involves supporting the document management process in a sterile GMP environment, ensuring compliance with global and site procedures. The ideal candidate will possess a Bachelor’s degree in a relevant field and have at least two years of experience in quality assurance or aseptic manufacturing. This position offers the chance to work collaboratively with various departments, enhancing your skills in a dynamic and fast-paced setting. If you're detail-oriented and thrive in a challenging environment, this opportunity is perfect for you.

Qualifications

• 2+ years of experience in quality assurance or manufacturing compliance.
• Knowledge of GxP Quality Systems and relevant regulations.

Responsibilities

• Ensure compliance with document management processes in a GMP environment.
• Review and approve SOPs and manage document lifecycle requirements.

Skills

Analytical Problem Solving

Strong Communication Skills

Attention to Detail

Flexibility

Organizational Skills

Education

Bachelor’s Degree in Science

Bachelor’s Degree in Information Science

Tools

TruVault

Veeva

Microsoft Office

Job 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 and natural killer (NK) cell-based immunotherapy.

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) in 2017. 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 (1st Shift) as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Document Control Specialist (1st shift) 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.

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.
• Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Key Relationships: 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 guidance (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.
• 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.
• Proficient knowledge of Microsoft Office.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.