Senior Quality Assurance Specialist, External Manufacturing
3 weeks ago
The Sr. Quality Assurance Specialist, External Manufacturing will play a pivotal role in ensuring that all external batch records adhere to Vaxcyte's quality standards and regulatory requirements.
Key Responsibilities- Batch Record Review: Reviewing executed batch records, resolving discrepancies, and effectively working with cross-functional teams.
- Product Disposition: Performing activities associated with disposition of product, including document review and shipping.
- Problem Solving: Representing Quality Assurance in support of Deviations, Change Controls, CAPAs, etc.
- Technology Transfer: Participating as a QA representative on Technology Transfer Teams, providing guidance on QA procedures and policies.
- Documentation and Reporting: Reviewing, editing, or approving controlled documents and maintaining accurate documentation of related quality activities.
- Regulatory Compliance: Ensuring all disposition-related activities comply with global regulatory requirements.
- Cross-functional Collaboration: Working closely with manufacturing and external vendors to address quality issues and support product development and commercialization.
- Continuous Improvement: Driving improvements in batch record review processes and procedures.
- Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.
- Minimum of 5+ years of experience in quality assurance, batch record review, manufacture, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry.
- Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards.
- Demonstrated experience managing batch record review and deviations.
- Excellent problem-solving skills and the ability to manage complex investigations and root cause analyses.
- Strong written and verbal communication skills.
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San Carlos, California, United States Vaxcyte Full timeAbout VaxcyteVaxcyte is a clinical-stage vaccine innovation company dedicated to protecting humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections that have serious and costly health consequences when left unchecked.Job SummaryThe Sr. Quality Assurance Specialist, External Manufacturing will play a...
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