Stephanie Catoe

Quality Compliance Engineer Iii (Bioproduction Group, Purification Network) @Thermo Fisher Scientific

Bedford, MA, US

Act as a direct liaison between cross-functional groups to ensure consistency to applicable regulations and make decisions regarding product compliance. Assigned to processes and projects of moderate to high complexity, perform compliance assessments, make decisions regarding quality and regulatory requirements, and ensure alignment to current regulations with little dependence on others. Responsible for support of Drug Master File submission activities, including the creation of Regulatory Support Packages and Letters of Authorization. Responsible for the management of the product issue process and the execution of decisions regarding product holds and field actions/recalls at the Network level. Work closely with New Product Introductions as the Quality representative to ensure compliance requirements are met through the Product Commercialization Process. Active member of the Complaints Team with responsibilities that include complaint management, leading cross-functional investigations, issuing of customer facing investigation reports, and quality metrics/KPI\'s at the Network level.

University of North Carolina at Wilmington

Masters, Chemistry

Erskine College

Bachelors, Chemistry