Senior Quality Assurance Specialist, External Manufacturing

3 weeks ago


San Carlos, California, United States BioSpace, Inc. Full time
Job Summary

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.
Requirements
  • 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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