Lisa Mello serves as the Director of Quality Assurance - Quality Systems at RoslinCT, where she plays a pivotal role in establishing and enhancing the Quality Management System (QMS) for a leading cell therapy Contract Development and Manufacturing Organization (CDMO). With a Bachelor of Science...
Lisa Mello serves as the Director of Quality Assurance - Quality Systems at RoslinCT, where she plays a pivotal role in establishing and enhancing the Quality Management System (QMS) for a leading cell therapy Contract Development and Manufacturing Organization (CDMO). With a Bachelor of Science degree in Chemistry, complemented by a Biochemistry concentration and a Biology minor, Lisa brings a robust scientific foundation to her work. Her expertise spans a wide array of regulatory frameworks, including 21 CFR 820/803, 21 CFR 210 & 211, ISO 9001, ISO 13485, and 21 CFR Part 11, positioning her as a key player in ensuring compliance and quality in both drug products and medical devices.
At RoslinCT, Lisa has successfully grown and led a dynamic team dedicated to the development, implementation, and optimization of critical QA processes during the company's start-up phase. Her leadership has been instrumental in streamlining processes such as Corrective and Preventive Actions (CAPA), Deviation Management, Change Control, and Supplier Quality Management. Lisa's hands-on experience with audits and inspections, coupled with her proficiency in electronic QMS administration, has significantly enhanced the organization's ability to maintain high-quality standards and regulatory compliance.
Her technical skills are complemented by a strong understanding of analytical techniques, including High-Performance Liquid Chromatography (HPLC), Karl Fischer titration, and UV-Vis spectroscopy, which are essential for method validation and transfer. Lisa’s commitment to continuous improvement and her strategic approach to training and document control ensure that RoslinCT remains at the forefront of quality assurance in the rapidly evolving field of cell therapy. Through her expertise and leadership, Lisa Mello exemplifies a dedication to excellence that drives both organizational success and patient safety.
