QA Document Specialist II

QA Document Specialist II 

Summary:

Vaxcyte is looking for a talented QA Document Specialist II, who will be responsible for managing manufacturing documents in a GXP compliant environment. This includes, but is not limited to, batch records, specifications, and memos. The role is focused on maintaining documentation in the Quality Systems associated with the manufacturing and testing of our vaccines and preparing for future clinical trials.

Essential Functions:

• 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).

Requirements:

Bachelor’s BA/BS degree or equivalent experience and minimum 2 years of biopharmaceutical industry experience. Other combinations of education and/or experience may be considered.

• 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; effective management of groups of professionals to achieve desired results.
• 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.
• Working knowledge with SmartSheet, Microsoft Office Suite, Word, Excel, PowerPoint, Visio, and Adobe.

Reports to: Director, Quality Assurance, Drug Product

Location: San Carlos, CA

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

Salary Range: $88,000 – $103,000