Document Control Specialist

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.

Education:

• High school diploma with a minimum of 5 years of document control experience in a GMP-regulated pharmaceutical, biologic, or medical device environment.