Document Control Specialist - Contract

Strong computer skills, including proficiency with Microsoft Word, Excel, Adobe Acrobat, and Visio; advanced Microsoft Word functionality is preferred. Excellent interpersonal and communication skills, with the ability to collaborate effectively with internal customers and cross-functional partners.

Duties:

Title - Document Control Specialist
Location - Newark CA
Duration - 12 Months (Possibility of extension)
Hybrid 3-4 days on site
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 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.

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.

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