Document Control Specialist III

Vaxcyte • San Carlos, CA

1d • $115,000 - $134,000 • Hybrid

About The Position

Vaxcyte is looking for a talented Document Control Specialist, who will be responsible for the processing of GxP documentation as part of the Quality Management System. This includes, but is not limited to, Standard Operating Procedures, Work Instructions, Forms, and Templates.

Requirements

• 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.

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

Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees