Quality Assurance Specialist III, External Manufacturing: Regulatory Expert Wanted

5 days ago


San Carlos, California, United States Lifelancer Full time

Vaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to protect humankind from bacterial diseases.

As a Quality Assurance Specialist III, External Manufacturing, you will play a pivotal role in ensuring compliance with regulatory requirements and quality standards. Your primary responsibilities include:

GxP Batch Record Review

  • Reviewing executed batch records for accuracy and compliance with cGMP regulations
  • Documenting review comments and collaborating with cross-functional teams to resolve issues

Product Disposition

  • Performing activities associated with product disposition, including document review and approval
  • Maintaining accurate documentation of related quality activities

Regulatory Compliance

  • Ensuring all disposition-related activities comply with global regulatory requirements, including FDA, EMA, and ICH guidelines

Requirements:

Education and Experience

  • Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or a related field
  • Minimum 5+ years of experience in quality assurance, batch record review, manufacture, or quality systems management within the pharmaceutical industry

Skills and Qualifications

  • Strong knowledge of cGMP, ICH guidelines, and international pharmaceutical quality standards
  • Demonstrated experience managing batch record review and deviation resolution
  • Excellent problem-solving skills and attention to detail

Location: San Carlos, CA; Open to remote work. Salary Range: $123,000 - $134,000 (SF Bay Area). Vaxcyte offers comprehensive benefits and an equity component.



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