Alex Au

Alex Au has a diverse work experience spanning several companies and positions. In 2001, they began their career as a Production Operator at The Coca-Cola Company. Alex later transitioned to the role of Quality Assurance Technician, where they were responsible for analyzing and releasing raw and finished products, maintaining laboratory equipment, and training new technicians. Alex then became an Internal Auditor, where they organized and updated work documents, conducted internal audits, and made recommendations on external audits.

In 2015, Alex joined BioDuro as a Quality Assurance Specialist, and later became a Senior Quality Assurance Associate. In these positions, they engaged in client audits, developed internal processes to ensure compliance, reviewed and approved SOPs and validation documents, and facilitated training for GMP employees. Alex also managed a comprehensive vendor management program, reviewed batch records, and provided support for manufacturing activities. Additionally, Alex hosted external audits and performed internal quality audits, while also providing recommendations for process improvements.

From 2020 to 2022, Alex served as a Senior Quality Assurance Specialist at Heron Therapeutics, Inc. Their responsibilities included managing CMO/CPO relationships, reviewing and approving batch records, and overseeing the Supplier Quality Management program. Alex also reviewed and approved deviations, change controls, and CAPAs, ensuring compliance with industry guidelines and specifications.

Alex's most recent work experience is as a GMP QA Compliance professional at Artiva Biotherapeutics, starting in 2023. Further details about this role are not provided.

Alex Au attended Grossmont College from 2000 to 2004, earning an Associate's Degree in Forensic Technology. After that, from 2004 to 2008, they attended San Diego State University and obtained a Bachelor's Degree in Criminal Justice in Public Administration.