Carissa Heart
About Carissa Heart
Carissa Heart is a Quality Management System Specialist with extensive experience in enhancing quality management capabilities across multiple organizations. She has a strong educational background in Health Care Administration and has successfully implemented quality systems that comply with regulatory standards.
Work at Supernus Pharmaceuticals
Carissa Heart serves as a Quality Management System Specialist at Supernus Pharmaceuticals, Inc. since 2020. In this role, she has focused on enhancing quality management processes within the organization. Her responsibilities include coordinating quality management system activities across 22 departments, which impacts approximately 200 GMP personnel. She has also led the development and implementation of a Quality System that ensures compliance with FDA CFR Part 11 and Annex 11 regulations.
Education and Expertise
Carissa Heart studied at Brown Mackie College-Louisville, where she pursued a Bachelor's of Science in Health/Health Care Management from 2013 to 2015, following an Associate's degree in Business and Healthcare Administration from 2011 to 2013. Her educational background has equipped her with the necessary skills to manage quality systems effectively in the healthcare sector.
Background
Prior to her current position, Carissa Heart worked at US WorldMeds as a Quality Management System Specialist from 2019 to 2020. She also held the role of Administrative Assistant at KentuckyOne Health from 2015 to 2019. Earlier in her career, she worked as a Clerk at the United States Postal Service from 2013 to 2015 and as Head Receptionist at Bardstown Road Animal Clinic in 2012.
Achievements
Carissa Heart has designed and implemented the Veeva Quality Suite for two different companies, significantly enhancing their quality management capabilities. She developed and managed an Electronic Document Management System (EDMS) for the creation, maintenance, and control of GxP documents and quality processes. Additionally, she has coordinated quality management system activities across multiple departments and interacted with contract pharmacovigilance providers to ensure timely documentation and resolution of product quality complaints.