Quality Assurance Specialist - External Manufacturing

2 days ago

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Vaxcyte

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

Description

• Join our Mission to Protect Humankind! • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. • The Quality Assurance Specialist III will ensure GxP external batch records adhere to Vaxcyte’s quality standards and regulatory requirements.

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 deviation resolution • Great organization skills and have an attention to detail • In-depth understanding of biologics manufacturing operations • Good ability to prioritize multiple assignments and changing priorities • Excellent problem-solving skills and the ability to manage complex investigations and root cause analyses • Strong written and verbal communication skills, with the ability to clearly present quality issues to cross-functional teams

Benefits

• Comprehensive benefits • Equity component