Jessica Gillis
About Jessica Gillis
Jessica Gillis is a Validation Engineer III at Organogenesis, with extensive experience in quality assurance and validation across various companies in the medical and biotechnology sectors. She holds a Bachelor of Science in Biology and Pre-Medicine from Norwich University and has worked in multiple roles that emphasize her proficiency in regulatory standards and clean room environments.
Work at Organogenesis
Jessica Gillis has been employed at Organogenesis as a Validation Engineer III since 2020. In this role, she is responsible for ensuring compliance with regulatory standards and maintaining the quality of products. Her position involves writing, reviewing, and executing qualification protocols and research studies, contributing to the overall quality assurance processes within the organization.
Previous Experience in Quality Assurance
Prior to her current role, Jessica Gillis held several positions in quality assurance and validation across various companies. She worked as a Senior Design Assurance Engineer Consultant at AngioDynamics for eight months in 2015-2016, and as a Senior Quality and CAPA Engineer Consultant at Getinge for eight months in 2017. Additionally, she served as a Validation Specialist II at Rapid Micro Biosystems from 2018 to 2019 and as a Contract QA Validation Engineer II at Real Staffing in 2019.
Educational Background
Jessica Gillis studied at Norwich University, where she earned a Bachelor of Science in Biology with a focus on Pre-Medicine from 1997 to 2001. She also attended Rivier University, furthering her education in relevant fields. Her academic background provides a strong foundation for her career in validation and quality assurance.
Regulatory Standards and Expertise
Jessica Gillis possesses extensive knowledge of various regulatory standards, including USP, GLP, GCP, and cGMP. She is experienced in clean room environments and is knowledgeable in multiple ISO standards, such as ISO 10993, ISO 13485, ISO 14971, and ISO 9001. This expertise is critical in her roles within the biotechnology and medical device industries.
Adaptability and Skills Development
Jessica Gillis has demonstrated a strong ability to adapt to fast-moving environments with shifting priorities and changing requirements. She possesses the capability to learn multiple skills, languages, and cultures, indicating a commitment to continuous learning and professional development throughout her career.