Document Control Specialist

$115,000 - $124,000/Yr

Vaxcyte - San Carlos, CA

Full-time - Entry Level

San Carlos, CA

Professional, Scientific, and Technical Services

About the position

Vaxcyte is seeking a Document Specialist to manage manufacturing documents in a GXP compliant environment. This role is crucial for maintaining documentation in the Quality Systems related to the manufacturing and testing of vaccines, as well as preparing for future clinical trials. The Document Specialist will ensure compliance with internal procedures and regulatory standards while collaborating with various teams to manage document lifecycles effectively.

Responsibilities

• Maintain Quality Systems documentation in Veeva and other electronic systems as required.
• Manage the lifecycle of GMP documents in Veeva, including creation, revision, approval, distribution, and archival.
• Collaborate with quality assurance, external vendors, functional areas, and the Project Management team for document management.
• Organize and ensure accurate filing systems for electronic and paper-based GMP documents.
• Support internal and regulatory audits as appropriate.

Requirements

• Bachelor's BA/BS degree or equivalent experience.
• 2+ years of biopharmaceutical industry experience.
• Experience with managing key Quality Management System processes (e.g., Document Control, Change Management, Training).
• 2+ years of experience with document management utilizing EDMS systems.
• Experience with Veeva QualityDocs preferred.
• Familiarity with documents and records associated with GxP manufacturing and testing activities.
• Understanding of current regulatory expectations including 21CFR Part 11 requirements.
• Demonstrated ability to collaborate and influence across the organization.
• Strong professional interpersonal and communication skills, both verbal and written.
• Strong attention to detail and organizational skills.

Nice-to-haves

• Working knowledge with SmartSheet, Microsoft Office Suite, Word, Excel, PowerPoint, Visio, and Adobe.

Benefits

• Competitive compensation package
• Comprehensive benefits
• Equity component