Lourdes Hernandez

Quality Systems Manager @ Kite Pharma

About Lourdes Hernandez

Lourdes Hernandez is a Quality Systems Manager at Kite Pharma, with extensive experience in quality assurance and manufacturing across several prominent biotech companies. She holds a Bachelor's degree in Biology from the University of Puerto Rico-Mayaguez and is certified as a Quality Auditor by the American Society of Quality.

Work at Kite Pharma

Lourdes Hernandez currently serves as a Quality Systems Manager at Kite Pharma, a position she has held since 2022. Prior to this role, she worked as a Quality Systems Specialist III at the same company starting in 2020. In her capacity as Quality Systems Manager, she manages the Change Control Review Board, ensuring that change controls are assessed by the necessary functions and executed according to established plans and timelines. She also provides Quality Systems support during inspections and develops training materials to facilitate training on quality systems.

Previous Experience in Quality Assurance and Manufacturing

Lourdes Hernandez has extensive experience in quality assurance and manufacturing across several prominent organizations. She worked at Emergent BioSolutions as a Quality Assurance Specialist from 2018 to 2020. Prior to that, she was a Quality Assurance Specialist at AstraZeneca from 2015 to 2018 and held the position of Production Technician III there from 2009 to 2015. Her earlier experience includes working as a Manufacturing Associate at Baxter Bio Science from 2008 to 2009 and as a Lead Manufacturing Associate at Amgen from 2006 to 2008.

Education and Expertise

Lourdes Hernandez earned her Bachelor's degree in Biology from the University of Puerto Rico-Mayaguez, completing her studies from 2001 to 2006. She is certified as a Quality Auditor by the American Society of Quality (ASQ). Her expertise includes developing and executing rigorous test plans to validate process functionality and acting as a Quality System Subject Matter Expert (SME) for regulatory inspections and internal audits.

Language Proficiency and Skills

Lourdes Hernandez is fluent in both English and Spanish, with the ability to read, write, and interpret technical documents in both languages. She possesses strong diagnostic and troubleshooting skills, along with proficiency in data visualization. These skills enhance her effectiveness in managing quality systems and supporting regulatory compliance.

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