Summer Intern, Quality Assurance
About The Position
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’s Summer Internship program offers students with an opportunity to gain valuable work experience that complements their college curriculum with relevant hands-on work that can shape their future career pathing and interests. As a Quality Intern for Vaxcyte, you will work on a project as outlined below: Review drug substance manufacturing batch records to identify documentation issues that impact QA review timelines. Analyze QA review data and help develop tools to improve right-first-time execution and first-pass approval rates. Support documentation quality and data integrity efforts in partnership with QA and Manufacturing teams. Evaluate and organize documents in Veeva QualityDocs, and improve metadata accuracy. Present findings and recommendations to improve QA efficiency, compliance, and document management processes. The Intern will learn and practice: Defining and establishing baseline metrics for execution and QA batch record review processes. Analyzing performance metrics and identifying opportunities for measurable improvement. Designing manufacturing-focused QA tools suitable for pilot implementation. Evaluating data and formulating evidence-based recommendations for ongoing QA metric tracking. Reviewing and navigating CMC documentation within Veeva QualityDocs through hands-on application. Program Details: The Internship will begin in June and will be around 10 weeks (8 hours per day) in duration at our San Carlos, California location.
Requirements
- Must be pursuing a Bachelor’s Degree (enrolled student with at least 1 year at university completed) with a focus on Biological Sciences, Engineering, or a related life science field.
- Proficiency in Microsoft Office.
- Strong attention to detail and work quality.
- Demonstrates collaboration and teamwork.
- Demonstrates curiosity, enthusiasm, and a strong willingness to learn.
- Reliable, responsible, and dedicated to meeting commitments.
Responsibilities
- Review drug substance manufacturing batch records to identify documentation issues that impact QA review timelines.
- Analyze QA review data and help develop tools to improve right-first-time execution and first-pass approval rates.
- Support documentation quality and data integrity efforts in partnership with QA and Manufacturing teams.
- Evaluate and organize documents in Veeva QualityDocs, and improve metadata accuracy.
- Present findings and recommendations to improve QA efficiency, compliance, and document management processes.
- Defining and establishing baseline metrics for execution and QA batch record review processes.
- Analyzing performance metrics and identifying opportunities for measurable improvement.
- Designing manufacturing-focused QA tools suitable for pilot implementation.
- Evaluating data and formulating evidence-based recommendations for ongoing QA metric tracking.
- Reviewing and navigating CMC documentation within Veeva QualityDocs through hands-on application.
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What This Job Offers
Career Level
Intern
