Carol Bartnett Email & Phone Number

Greater St. Louis Area

Manage the Novus Quality System in North America and provide leadership in supporting the Novus Quality Management System including:1) Management, development and training on quality procedures;2) Maintaining third-party certifications in North America (FAMI-QS, GMP+, Safe Feed/Safe Food, ISO 9001);3) Management and investigation of customer complaints for NORAM;4) Organizing monthly quality meetings for management review of problems and examining trends to allow for adequate corrective/preventive actions;5) Ensuring compliance of manufacturing plants to the Food Safety Modernization Act regulations for Animal Feed including cGMPs, Hazard Analysis and Risk-Based Preventive Controls, Sanitary Transportation and Foreign Supplier Verification Programs.6) Ensuring traceability, safe manufacturing, safe handling, and accountability of raw ingredients, in-process materials, and finished products from supplier to Customer;7) Management of North American manufacturing plants for compliance to export and import regulatory requirements of different world areas; 8) Internal and external quality audits.

St. Louis, Missouri

Perform and direct microbial efficacy testing required for hard-surface disinfectants and topical antimicrobial products.Resolve technical issues and recommend solutions for customers related to cleaning and disinfection in cleanrooms.Collaborate with formulators and chemists to successfully launch new products within specified timelines.Develop and implement policies, SOPs and test methods compliant with regulatory and safety guidelines.Perform supplier quality audits.Liaison with contract laboratories to assure completion of microbiological efficacy testing in accordance with FDA and EPA regulations.

St. Louis, Missouri

Voluntarily left GSK to support family business. Assisted with market expansion, customer accounts, and business management.

St. Louis, Missouri

Led day to day operations in Quality Assurance Microbiology laboratoryWrote and implemented policies and standard operating procedures to maintain compliance with applicable regulatory standards Performed USP microbiological tests for raw materials and finished products including Microbial Limits and Antimicrobial Effectiveness.Collaborated with engineers to design and maintain two USP Purified Water systems; performed microbiological sampling and testing for validation and routine analysisPerformed cleaning validation sampling and testing to justify cleaning frequency of manufacturing and packaging equipmentAudited laboratories and manufacturing areas to assess compliance with FDA requirements and cGMP regulationsDeveloped and presented training programs to laboratory and operations personnel to ensure thorough understanding of laboratory safety, Good Laboratory Practices, cGMP, and internal procedures Quality Department Employee of the Year, 1993

St. Louis, Mo

Conducted USP sterility testing of biopharmaceuticals. Perrformed environmental monitoring in aseptic processing areas to detect airborne and surface contaminants.

St. Louis, Missouri

Conducted USP sterility testing of radiopharmaceuticals.Performed environmental monitoring in cleanrooms and adjoining areas Sampled and tested USP WFI.