Atricure, Inc.
Manager Sterilization and Environmental Controls
Atricure Aug 2018 - Nov 2018
Sterilization and Environmental Controls Specialist
Kbi Biopharma Jul 2018 - Aug 2018
Quality System Consultant
Pfizer Jul 2018 - Jul 2018
Quality System Investigations Specialist
Avexis, Inc. Jun 2018 - Jun 2018
Health Authority Inspection Preparation
Education:
University of Kentucky;Ms;;
Master of Science, Masters
University of Kentucky
Master of Science, Masters, Biochemistry, Microbiology
Skills:
Fda Validation Gmp Capa Change Control Quality System Quality Assurance Sop Quality Control Biotechnology Pharmaceutical Industry Iso 13485 Medical Devices V&V 21 Cfr Part 11 Life Sciences Regulatory Requirements Aseptic Processing Quality Auditing Laboratory Pharmaceutics Technology Transfer Regulatory Affairs Manufacturing Clinical Trials Microbiology Glp Quality Management Testing Standard Operating Procedure Verification and Validation Iso 14971 Gamp Gxp Sterilization Clinical Development Biopharmaceuticals U.s. Food and Drug Administration R&D Process Improvement Computer System Validation Technical Writing Corrective and Preventive Action Lifesciences Clinical Research Oncology Business Process Improvement Good Laboratory Practice
Certifications:
Certified Manager of Quality/Operational Excellence Certified Quality Auditor Asq