Quality Assurance Senior Representative
July 19
🏢 In-office - Bay Area
Description
• As an on-site team of one, oversee the quality assurance activities at the Menlo Park site. • Conduct batch releases and manage quality control testing. • Ensure compliance with clinical stage manufacturing requirements, with a preference for experience in antibody or large molecule manufacturing. • Work closely with manufacturing, CMC and science teams on quality assurance tasks. • Participate in tech transfer from clinical production to commercial production within the next 1-2 years. • Collaborate with all staff to support consistent production at the Menlo Park site. • Implement and manage documentation and quality control procedures, updating obsolete procedures as necessary. • Contribute to the development of in-house raw material production, ensuring the facility meets regulatory and quality standards. • Contribute to the setup and management of a quality system for pipeline products, ensuring high standards for clinical manufacturing.
Requirements
• Proven experience (5+ years) in quality assurance, ideally within clinical-stage manufacturing for a biotech company. • Familiarity with antibody manufacturing is highly desirable. • Strong self-motivation and ability to work with minimal oversight. • Excellent communication skills to work effectively with cross-functional teams.
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