Vaxcyte
Pharmaceutical
QualityAssuranceSpecialistIII,ExternalManufacturing
Neural analysis suggests this role is
optimal for Senior candidates.
“Quality Assurance Specialist III, External Manufacturing at Vaxcyte. Skills: Batch record review, External manufacturing, Regulatory compliance. Review executed batch records. Review product or program specific documents”
Industry & Context.
Problem solving; Investigations; Root cause analyses
What They're Looking For.
Must Have
Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or related field, Minimum 5 years of experience in quality assurance, batch record review, manufacturing, or quality systems management, Knowledge of cGMP, ICH guidelines, FDA regulations, and other international pharmaceutical quality standards, Demonstrated experience managing batch record review and deviation resolution, In-depth understanding of biologics manufacturing operations, Good ability to prioritize multiple assignments and changing priorities, Excellent problem-solving skills, Ability to manage complex investigations and root cause analyses, Written and verbal communication skills, Ability to clearly present quality issues to cross-functional teams
Nice to Have
Electronic batch record review experience
What You'll Do.
Review executed batch records
Review product or program specific documents
Review deviation and change control
Approve deviation and change control
Document batch review comments
Act as QA point of contact with CDMO
Perform activities associated with disposition of product
Approve disposition documents
Archive disposition documents
Represent Quality Assurance in Deviations
Represent Quality Assurance in Change Controls
Represent Quality Assurance in CAPAs
Participate in investigation
Participate in evaluation
Participate in problem resolution
Provide guidance on QA procedures
Provide guidance on QA policies
Review documents for internal transfers
Review documents for external transfers
Review controlled documents
Edit controlled documents
Approve controlled documents
Maintain accurate documentation of quality activities
Ensure disposition activities comply with global regulatory requirements
Work closely with global manufacturing
Work closely with external vendors
Address quality issues
Support product development
Support product commercialization
Drive improvements in batch record review processes
Drive improvements in batch record review procedures
Identify gaps in processes
Recommend solutions for processes
Implement best practices for processes
Participate in ERP platform implementation
Support internal audits
How You'll Work.
Team & Collaboration
Cross functional team; External vendors; Global manufacturing
Communication Scope
Written communication; Verbal communication
Full Job Description
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 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. Essential Functions: GMP Batch Record and Product or Program Document: reviewing executed batch records (paper and electronic), product
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