Tracey Hlucky, Cqa, Cmq/Oe (Asq)
About Tracey Hlucky, Cqa, Cmq/Oe (Asq)
Tracey Hlucky is a Senior Manager of Product Distribution Quality Assurance at Kite Pharma, overseeing quality assurance for over 25 Authorized Treatment Centers in the U.S. She has extensive experience in quality management and education, having held various roles in organizations such as Grifols and the American Red Cross.
Work at Kite Pharma
Tracey Hlucky serves as the Senior Manager of Product Distribution Quality Assurance at Kite Pharma, a position she has held since 2018. In this role, she oversees more than 25 of Kite’s Authorized Treatment Centers across the United States. She is responsible for managing and monitoring site deviations and Corrective and Preventive Actions (CAPAs) through the AGILE system. Additionally, she plays a key role in ensuring compliance with the Risk Evaluation and Mitigation Strategy (REMS) programs for qualified treatment centers.
Previous Experience at Grifols
Tracey Hlucky worked at Grifols in various capacities. From 2015 to 2016, she held the position of Center Quality Manager in Akron, Ohio. Following this, she served as Regional Quality Manager from 2016 to 2017. During her tenure at Grifols, she developed a simulation of Kite’s Apheresis Collection Application System (ACAS) for training sessions, enhancing the quality of training provided to staff.
Education and Expertise
Tracey Hlucky has a diverse educational background. She earned an Associate of Arts and Sciences (A.A.S.) in Medical/Clinical Assistant from Stark State College of Technology from 1996 to 1999. She also holds a Bachelor of Arts (BA) in Biology and Chemistry from The University of Akron, completed between 2001 and 2010. Additionally, she obtained a Certificate in Cellular Therapy from The George Washington University from 2018 to 2019. Her expertise is further supported by her completion of Adobe Captivate Specialist training in May 2019.
Teaching Experience
Tracey Hlucky served as an Adjunct Instructor at Brown Mackie College from 2009 to 2014. During her five years in this role, she contributed to the education of students in her field, sharing her knowledge and experience in quality assurance and clinical practices.
Role at American Red Cross
Before her roles at Grifols and Kite Pharma, Tracey Hlucky worked at the American Red Cross as an Apheresis Team Supervisor from 2005 to 2015. In this position, she was responsible for overseeing apheresis procedures, ensuring quality and compliance within the organization.