Job Description:
We are seeking a detail-oriented and collaborative Document Control Specialist to join our Quality team at our Newark, CA facility. This role offers an opportunity to support critical document control activities within a GMP-regulated environment while contributing to our work in the exciting field of allogeneic CAR T cell therapy.
The Document Control Specialist supports controlled-document lifecycle activities used for production, validation, testing, and quality operations. The ideal candidate is a self-directed team member with strong prioritization skills who can work effectively both independently and in a collaborative team environment. This role helps strengthen efficient, compliant documentation practices while delivering accurate, timely results in a fast-paced environment. Responsibilities:
" Provide responsive support to internal customers, promoting timely project execution and a positive customer experience.
" Partner with internal customers to create and revise procedures and execution documents in alignment with established processes and timelines.
" Process, distribute, and maintain GMP documentation, including production, testing, validation, and quality records.
" Perform document control reviews using standard checklists to verify appropriate templates, formatting, punctuation, and applicable document control requirements.
" Support continuous improvement of document control tools, checklists, and SOPs that define and strengthen standard team processes.
" Perform additional duties and assignments as requested by management to support Quality team objectives.
Hybrid 3-4 days on site |
| Skills: | Requirements:
" High school diploma with a minimum of 5 years of document control experience in a GMP-regulated pharmaceutical, biologic, or medical device environment.
" Strong computer skills, including proficiency with Microsoft Word, Excel, Adobe Acrobat, and Visio; advanced Microsoft Word functionality is preferred.
" Experience using Veeva QualityDocs or a comparable electronic document management system.
" Strong organizational skills and attention to detail, with the ability to manage multiple priorities accurately and efficiently.
" Excellent interpersonal and communication skills, with the ability to collaborate effectively with internal customers and cross-functional partners.
" Experience maintaining organized documentation or records to support record retention practices.
" Exposure to validation processes and documentation, Process Development, and validated electronic computer systems is preferred. |