Quality Assurance Specialist III, External Manufacturing

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3> <div>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. </div> <div> </div> <div><strong>WHAT</strong> we do is every bit as important as <strong>HOW</strong> we do it! Our work together is guided by four enduring core values:</div> <div> </div> <div>*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.</div> <div> </div> <div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div> <div> </div> <div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div> <div> </div> <div>*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3> <p>The Quality Assurance Specialist (QA) III, External Manufacturing will play a pivotal role in ensuring that all GxP external batch records, quality records adhere to Vaxcyte’s quality standards and regulatory requirements. This individual will perform activities supporting dispositioning product while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Vaxcyte’s Standard Requirement Documents. The ideal candidate will possess in-depth knowledge of cGMP (current Good Manufacturing Practices) and regulatory guidelines within the pharmaceutical industry.</p> <h3>Essential Functions:</h3> <ul> <li>GMP Batch Record and Product or Program Document: reviewing executed batch records (paper and electronic), product or program specific documents, deviation and change control review and approval, documenting batch review comments, and effectively working with cross functional team, may be the primary QA point of contact with CDMO.</li> <li>Product Disposition: Performing activities associated with disposition of product (e.g. document review and approval, docum