Leanne Tu
About Leanne Tu
Leanne Tu is a QA Ops Specialist II at Kite Pharma, with a strong background in quality assurance and validation processes in the medical device and biotech industries. She holds a Master of Science in Quality Assurance from Kennesaw State University and has previously worked in various roles at companies such as Hycor Biomedical LLC and Biomerica, Inc.
Work at Kite Pharma
Leanne Tu currently serves as a QA Ops Specialist II at Kite Pharma, a position she has held since 2019. In this role, she is responsible for ensuring quality assurance operations align with regulatory standards and company policies. Her expertise in quality management systems and compliance with FDA regulations supports Kite Pharma's mission in the biotechnology sector. The company focuses on developing innovative cell therapies for cancer treatment, and her contributions are integral to maintaining high-quality standards in product development.
Education and Expertise
Leanne Tu earned a Master of Science in Quality Assurance from Kennesaw State University, where she studied from 2013 to 2017. Prior to this, she obtained a Bachelor’s Degree in Biology from the University of California, Los Angeles, completing her studies from 2003 to 2007. Her educational background provides a strong foundation in both biological sciences and quality assurance practices, particularly in the medical device industry, where she has developed expertise in ISO 13485 standards.
Background in Quality Assurance
Leanne Tu has extensive experience in quality assurance and validation within the biotechnology and medical device sectors. She began her career as a Production Technician at Focus Diagnostics from 2007 to 2009, followed by a role as Technical Support at Biomerica, Inc. from 2009 to 2013. She then worked at Hycor Biomedical LLC, first as a Validation Engineer from 2013 to 2017 and later as a Quality Control Stability Supervisor from 2017 to 2019. This diverse background has equipped her with a comprehensive understanding of verification and validation processes.
Achievements in Quality Control
Throughout her career, Leanne Tu has demonstrated a commitment to quality control and compliance with industry standards. Her roles have involved significant responsibilities related to FDA regulations, which are critical for maintaining product safety and efficacy in the biotech field. Her work at Hycor Biomedical LLC and her current position at Kite Pharma highlight her ability to navigate complex regulatory environments and contribute to high-quality product outcomes.