QA Document Specialist II (contract)

Join our Mission to Protect Humankind! 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: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary: The Contract Document Specialist II will provide critical support for managing Stability documents in Veeva electronic Document Management System (EDMS), ensuring timely processing of documents while adhering to internal procedures and requirements in a GXP compliant environment. The position requires strong attention to detail, organizational skills, and the ability to collaborate effectively with cross-functional teams. Essential Functions:

• Perform document specialist functions in Quality Assurance, including managing the lifecycle of Stability documents in Veeva and other electronic systems where required, including creation, revision, approval, distribution and archival, ensuring compliance with internal procedures and regulatory standards.
• Work closely with Project Management, Stability, Quality Assurance and other functional areas as well as external vendors for daily management of routing, revisions, approval, and filing of documents within defined timelines.
• Organize and ensure accurate and reliable filing systems for all GMP documents.

Requirements:

• Bachelor’s BA/BS degree or equivalent experience and minimum of 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).
• 2+ years of experience with document management utilizing EDMS systems. Experience with Veeva QualityDocs strongly preferred.
• Familiarity with documents and records associated with GxP testing activities.
• Understanding of current regulatory expectations including 21CFR Part 11 requirements.
• Demonstrated ability to collaborate cross functionally.
• 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 Microsoft Word, Excel, Adobe and PowerPoint.

Reports to: Senior Manager, Quality Assurance Location: San Carlos, CA; Open to Remote Expected Contract Length: 6-7 months Hourly Range: $43.00 - $47.00 (SF Bay Area) We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Apply tot his job Apply To this Job