Caroline Shimp
About Caroline Shimp
Caroline Shimp is the Manager of Quality Systems at Insmed Incorporated, where she focuses on training and compliance in Good Manufacturing Practices. She has extensive experience in quality assurance and auditing across several pharmaceutical companies, holding an ASQ-CQA certification and specializing in inspection readiness and CAPA system management.
Work at Insmed
Caroline Shimp has been employed at Insmed Incorporated as the Manager of Quality Systems since 2022. In this role, she conducts New Hire GMP Orientation Training and serves as an Annual cGMP Trainer. Her responsibilities include ensuring compliance with quality standards and managing quality systems within the organization. She is based in Bridgewater, New Jersey.
Previous Experience in Quality Assurance
Before joining Insmed, Caroline Shimp held several positions in quality assurance. She worked at G&W Laboratories as a Senior Quality Auditor from 2016 to 2018 and as a Senior Quality Systems Analyst from 2013 to 2016. At Cosette Pharmaceuticals, Inc., she served as Manager of Quality Assurance from 2020 to 2021 and as Senior Auditor in QA from 2018 to 2020. Additionally, she worked at Teva Pharmaceuticals as a Quality Assurance Document Control Coordinator from 2003 to 2011 and as an Associate Auditor I from 2011 to 2013.
Education and Expertise
Caroline Shimp holds a Bachelor of Arts degree in English and Journalism from the University of Delaware. She is certified as an ASQ-CQA, indicating her expertise in quality auditing. Furthermore, she is a certified Kepner-Tregoe Program Leader, which focuses on structured problem-solving and decision-making processes.
Regulatory Compliance and Quality Management Skills
Caroline Shimp is experienced in handling regulatory inspections, including those from the FDA and DEA. She specializes in Inspection Readiness and CAPA System management, ensuring compliance and quality control. Her skills include developing and auditing Standard Operating Procedures (SOPs), managing Planned Deviations, and utilizing TrackWise software for quality management and compliance tracking.
Product Management and Review Expertise
In her quality management roles, Caroline Shimp has demonstrated proficiency in managing Product Complaints and conducting Annual Product Reviews. Her experience in these areas contributes to her ability to maintain high standards of quality and compliance within the organizations she has worked for.