QA Document Specialist II

Vaxcyte • San Carlos, CA

116d • $89,000 - $103,000

About The Position

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: RETHINK CONVENTION, AIM HIGH, LEAD WITH HEART, and MODEL EXCELLENCE.

Requirements

• Bachelor's BA/BS degree or equivalent experience and minimum of 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 organization to gain support and commitment for team goals.
• Strong professional interpersonal and communications skills, both verbal and written.
• Strong attention to detail, organizational skills, ability to work in a faced paced environment.
• Ability to meet deadlines and multi-task efficiently.
• Working knowledge with SmartSheet, Microsoft Office Suite, Word, Excel, PowerPoint, Visio, and Adobe.

Responsibilities

• Maintenance of the Quality Systems documentation in Veeva (electronic document control system) and other electronic systems where required.
• Perform document specialist functions in QA, including managing the lifecycle of GMP documents in Veeva, including creation, revision, approval, distribution and archival, ensuring compliance with internal procedures and regulatory standards.
• Work closely with quality assurance, external vendors, functional areas and Project Management team 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 and paper-based GMP documents.
• Support audits as appropriate (internal and regulatory).

Benefits

• Comprehensive benefits
• Equity component

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree