- 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.
- Help 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.
- 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 has experience working in a cGMP manufacturing facility, 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.
- 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 with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
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QA Document Control Specialist I - Raritan, United States - Legend Biotech US
Description
Company InformationLegend 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 as part of the Quality team based in Raritan, NJ.
Role Overview
The Quality Assurance Document Control Specialist role is an exempt position responsible 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 & retention, and document issuance & reconciliation.
Key Responsibilities
#Li-onsite
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.
