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Tonnette Mastropolo
Associate Director, CQA Systems & Data Integrity at Eisai US
Professional Background
Tonnette Mastropolo is a seasoned Quality Assurance professional with extensive experience spanning the Pharmaceutical, Biotech, Clinical Manufacturing, and Clinical Research industries. With a career that has demonstrated a commitment to quality and compliance, Tonnette has honed her skills in various facets of Quality Control laboratories and Quality Assurance Compliance. Her expertise ranges from computer and equipment validation, Change Control, CAPA Verification, Investigations, to Auditing, establishing her as a versatile and knowledgeable leader in her field.
Throughout her professional journey, Tonnette has worked with prestigious organizations, including Eisai US, where she currently serves as the Associate Director for CQA Systems & Data Integrity. Her prior roles have included Senior IT Quality Validation Consultant and Quality Auditor in which she excelled at ensuring compliance with both internal and external regulatory requirements. Tonnette's experiences extend to her advantageous position at Hitachi Chemical Advanced Therapeutics Solutions, LLC, where her auditing skills and quality assurance measures were instrumental in promoting regulatory compliance and improving overall quality standards.
Tonnette's overarching goal is to maintain high quality in all manufacturing and laboratory processes, ensuring adherence to rigorous compliance standards that reflect her customer-focused approach. She thrives in environments that require a mixture of independence and collaboration, showcasing her ability to work effectively with diverse teams to achieve shared objectives
Education and Achievements
Tonnette Mastropolo's educational background sets a solid foundation for her impressive career in Quality Assurance. She pursued her Master’s degree in Computer Science at Pace University, where she acquired the technical skills essential for navigating the complexities of quality systems and data integrity within the life sciences sector. Additionally, her Bachelor’s degree in Chemistry from the State University of New York College at Oneonta provided her with a profound understanding of scientific principles, enhancing her capability to approach quality assurance with a critical and analytical mindset.
Her academic journey, remarkably complemented by extensive on-the-job training and industry experience, has equipped her with the tools necessary for excelling in cGMP compliance within laboratories and manufacturing areas.
Professional Experience and Notable Contributions
Tonnette's professional trajectory reflects a series of progressive roles that underscore her commitment to quality assurance and compliance. As the Associate Director of CQA Systems & Data Integrity at Eisai US, she plays an essential role in overseeing quality systems that govern data integrity and system validation. Tonnette is well-versed in the intricacies of validation processes, ensuring that both product safety and efficacy standards are met throughout the production lifecycle.
Prior to her role at Eisai US, Tonnette was instrumental as a Senior IT Quality Validation Consultant in Clinical QA, where she leveraged her vast knowledge of quality systems to enhance efficiency and compliance across multiple projects. Her tenure at Pfizer spanned various capacities, from Manager of Computer Systems Support to Manager of Validation, showcasing her adaptability and expertise in different aspects of quality assurance.
At Novartis, she served as a QA Computer Validation Specialist, where her rigorous oversight of validation processes was pivotal in ensuring adherence to compliance regulations. Each position contributed to Tonnette's growing reputation as a Quality Assurance expert, respected by her peers and organizations alike for her work ethic and strategic thinking.
Achievements
Tonnette Mastropolo's journey is decorated with numerous accomplishments that reflect her dedication to excellence in quality assurance. Her ability to ensure quality control in laboratory and manufacturing environments has resulted in significant improvements in compliance metrics and operational efficiencies. Notable achievements include successful audits and inspections leading to enhanced systems and processes compliant with current regulations, providing reassurance to stakeholders about the integrity of their products.
Her contribution to several cross-functional teams highlights her collaborative spirit, as she works seamlessly with others to troubleshoot quality assurance challenges and implement effective solutions. Tonnette's customer-focused approach ensures that stakeholder requirements and expectations are met and often exceeded, fostering trust and reliability in the processes she oversees.
In summary, Tonnette Mastropolo epitomizes professionalism and quality assurance excellence. Through her exemplary career in the pharmaceuticals, biotech, and clinical research industries, she continues to inspire others in her field to prioritize quality and compliance. Her extensive knowledge, combined with her unwavering commitment to quality, has made her a valued leader and innovator in Quality Assurance, whose contributions will undeniably continue to shape industry standards for years to come.
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