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:
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.
Essential Functions:
- 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
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.
Reports to: Director, Document Control
Location: San Carlos, CA; Hybrid
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $115,000 – $134,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.
