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Vaxcyte · 1 day ago

Document Control Specialist III

San Carlos, California, United States

Full-time

Hybrid

Mid, Senior Level

$115K/yr - $134K/yr

5+ years exp

Vaxcyte is a clinical-stage vaccine innovation company focused on creating high-fidelity vaccines to combat bacterial diseases. They are seeking a Document Control Specialist who will manage GxP documentation within the Quality Management System, ensuring compliance and effective document workflows.

BiopharmaBiotechnologyHealth Care

Comp. & Benefits

Responsibilities

Maintain Quality System documentation in Veeva (electronic document control system) and other electronic systems where required

Format documents to comply with Vaxcyte templates

Independently perform the QA document control function, managing document workflows in Veeva, tracking, processing, routing, distributing, and archiving documents/records with overall responsibility for document control

Engage key clients to understand expectations and problem areas and has the ability to address and resolve conflicts

Participate in developing and editing of new SOPs and work instructions

Ability to identify risks to program/process and propose solutions

Work closely with functional areas for daily management of routing, revisions, approval, and filing of documents within defined timelines

Organize and ensure accurate and reliable filing systems for all electronic

Qualification

GxP documentationVeeva VaultRegulatory complianceBiopharmaceutical experienceMicrosoft Office SuiteInterpersonal skillsOrganizational skillsAttention to detail

Required

Bachelor's BA/BS degree or equivalent experience and minimum of 5 years of biopharmaceutical industry experience. Other combinations of education and/or experience may be considered

Experience working with documents and records in a GxP environment relating to manufacturing and testing activities

Familiar with Veeva Vault in a Document Control capacity

Understanding of current regulatory expectations including 21CFR Part 11 requirements

Strong professional interpersonal and communications skills, both verbal and written, to provide clear direction for the business, vendors, and internal stakeholders

Strong attention to detail, organizational skills, ability to work in a faced paced environment

Ability to meet deadlines and multi-task efficiently

Proficient with Microsoft Office Suite, Word, Excel, PowerPoint