Quality Assurance Specialist III, External Manufacturing: Regulatory Expert Wanted
5 days ago
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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