Kayla Gotto
About Kayla Gotto
Kayla Gotto is a Senior Validation Engineer at Barry-Wehmiller Design Group, where she has worked since 2017, specializing in preparing trial master files for FDA audits. She holds a Bachelor of Science in Biological Sciences from UC Santa Barbara and has extensive experience in quality assurance and regulatory compliance.
Work at Barry-Wehmiller Design Group
Kayla Gotto has been employed at Barry-Wehmiller Design Group since 2017. She initially served as a Validation Engineer for four years before advancing to the position of Senior Validation Engineer in 2021. Her role involves preparing trial master files specifically for FDA audits and designing Standard Operating Procedures (SOPs). She works in the San Francisco Bay Area, contributing to the company's focus on quality assurance and validation processes.
Education and Expertise
Kayla Gotto earned a Bachelor of Science degree in Biological Sciences from the University of California, Santa Barbara, where she studied from 2007 to 2011. Her educational background supports her expertise in quality assurance, Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP). She possesses strong skills in Microsoft Office and public speaking, which complement her technical abilities in writing and executing Investigational Protocols (IPs) and Installation Operational and Performance Qualification Protocols (IOPQs).
Background in Quality Assurance
Kayla Gotto has a diverse background in quality assurance. She worked as a Quality Assurance Document Specialist at Revance Therapeutics for three months in 2012 and as a Quality Assurance Specialist at Insite Quality Assurance, Inc. for two months in 2013. Additionally, she served as the Director of Studies and Center Manager at Education International Cooperation (EIC) Group in Shanghai, China, from 2016 to 2017. This experience has equipped her with a comprehensive understanding of quality assurance processes and regulatory compliance.
Professional Skills and Management Capabilities
Kayla Gotto demonstrates strong professional skills in validation engineering and quality assurance. She is experienced in preparing trial master files for FDA audits and developing Standard Operating Procedures (SOPs). Her proficiency in writing and executing Investigational Protocols (IPs) and Installation Operational and Performance Qualification Protocols (IOPQs) showcases her technical expertise. Additionally, she exhibits management capabilities in her current role, contributing to the effective oversight of validation processes.