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Work Background
AbbottRisk Management Engineer II – Design Quality Assurance
Mar. 2021Responsible for management and application of site Quality Management System, specialized in Design Control and Risk Management. Managed all aspects of the risk management process for on-market products and new product development, including creating and maintaining product hazard lists, FMEAs, risk management plans, and reports. Acted as project manager to ensure timely delivery of risk management deliverables in compliance with internal and external standards. Led continuous improvement initiatives and collaborated with post-market surveillance and customer complaint teams. Provided leadership and guidance throughout all project phases, developed robust risk management processes, and implemented KPIs and metrics. Supported New Product Development (NPD) and compliance with ISO 14971 and IVDR. Critical contributor and Subject Matter Expert to remediation of legacy products under revised Quality Management System for Risk Management processes.
HGLQuality Assurance and Food Safety Manager
Aug. 2020 - Mar. 2021Topsham, Maine, United StatesLed all Quality Assurance and Food Safety functions, ensuring consistent product quality and regulatory compliance with FDA, FSMA, HACCP, and other regulations. Developed and implemented food safety, sanitation, and risk management programs while acting as the primary liaison with regulatory agencies. Created site-specific programs for GMPs, SSOPs, allergen control, and labeling. Managed HACCP and SSOP validations, third-party lab testing, and in-plant audits. Held authority to stop production and shipments in case of violations and responsible for providing detailed reports to upper management. Oversaw traceability programs and collaborated with vendors and customers on quality issues and audits.
Sazerac CompanyQuality Assurance & Food Safety
Jul. 2018 - Aug. 2020Supervised daily laboratory operations, ensuring adherence to HACCP and CGMP standards, while maintaining smooth coordination between the lab and production plant. Monitored production processes for compliance with food safety and quality regulations. Led training and mentoring efforts for laboratory staff, fostering skill development and improving performance. Collaborated with other departments to optimize workflow and resolve operational issues. Conducted regular inspections of equipment and facilities, analyzed production data to identify areas for improvement, and implemented corrective actions. Directed standardization of test methods, ensuring consistent results and regulatory compliance. Contributed to the selection and retention of QA staff, maintained lab schedules, and managed customer complaints and manufacturing defects. Assisted with ISO audits and developed food safety programs.
University of Maine at AugustaResearch Assistant
Sep. 2014 - Aug. 2020Augusta, MaineGraduate Research Assistant, Dubois Virology Lab, USM, Portland, ME (Sept. 2014 – May 2015)
Led a four-person team studying encapsulin genes from extremophiles, developed a NASA-funded proposal on immune response molecule delivery, and managed research processes, budgets, and data analysis. Research Assistant, UMA Microbiology Lab, Augusta, ME (May 2012 – Aug. 2014)
Led a 10-person team investigating pathogens in Maine wild turkeys, overseeing research organization, task delegation, and data analysis. Microbiology Faculty Assistant & Teaching Assistant, UMA Biology Dept., Augusta, ME (Sept. 2012 – May 2014)
Assisted in organizing microbiology lab classes and taught undergraduate students, providing hands-on instruction and supporting course delivery. Upper-Level Biology Tutor, UMA Learning Support Services, Augusta, ME (Sept. 2011 – May 2014)
Tutored and mentored students in biology, chemistry, and pre-med subjects, helping to improve academic performance.
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