Document Control Specialist
San Carlos, CA, USA
Posted on Saturday, January 20, 2024
Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
Vaxcyte is looking for a talented Document Control Specialist, 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.
- Maintenance of the Quality Systems documentation in Veeva (electronic document control system) and other electronic systems where required.
- Perform the QA document control function in QA and Regulatory Affairs, including managing document workflows in Veeva, tracking, processing, approval, distributing, and archiving documents/records with overall responsibility for document control processes.
- Work closely with 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.
- Maintain in-house training programs, including training matrix, training files, and audits of training files.
- Bachelor’s BA/BS degree or equivalent experience.
- Four (4) to six (6) plus-years of biopharmaceutical industry experience.
- Experience with managing key Quality Management System processes (e.g., Document Control, Change Management, Training).
- 2-4 years of experience with document management utilizing EDMS systems. Experience with Veeva QualityDocs and Veeva RIM 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.
- Proficient with the SmartSheet, Microsoft Office Suite, Word, Excel, PowerPoint and Project.
- All Vaxcyte employees require vaccination against COVID-19.
Reports to: Director, Document Control
Location: San Carlos, CA
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $110,000 - $122,000
Send resumes to:
825 Industrial Road, Suite 300
San Carlos, CA 94070
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.