Kelly Balascak

Kelly Balascak is a seasoned professional in quality engineering with extensive experience at Secant Group, LLC since November 2014, where roles have included Sr. Leader and Senior Quality Engineer, focusing on change control assessment, CAPA investigations, statistical analysis, and ISO 13485 compliance. Prior to Secant Group, Kelly worked as a Validation Engineer at Stryker and held validation consultant positions at Day & Zimmermann and Sanofi Pasteur, where responsibilities included technical writing and compliance with GMP standards. Kelly's foundational experience includes a pharmaceutical technology validation internship at Sanofi Pasteur and process improvement training in industrial operations. Kelly holds a Bachelor of Science in Bioengineering from Pennsylvania State University.