Shirley Fraser
About Shirley Fraser
Shirley Fraser is a Senior Consultant at Azzur Group and a Senior Quality Assurance Specialist at LSNE Contract Manufacturing, with over 15 years of experience in the biotechnology and pharmaceutical industries.
Title and Current Positions
Shirley Fraser holds the title of Senior Consultant in Quality Assurance at Azzur Group in the United States. Concurrently, she serves as a Senior Quality Assurance Specialist at LSNE Contract Manufacturing in Bedford, New Hampshire. Her dual roles underscore her deep expertise and commitment to the field of quality assurance.
Previous Experience
Shirley Fraser has a strong foundation in quality assurance, having worked at several prominent companies. She spent six years at Takeda as a Senior Quality Assurance Specialist in Lexington, Massachusetts. Prior to this, she was involved in quality assurance at Bristol-Myers Squibb. Her extensive experience in these roles has contributed significantly to her proficiency in managing quality assurance processes.
Education and Expertise
Shirley Fraser holds a Master of Science in Biotechnology from Tufts University, where she studied biotechnology and biotech engineering. With over 15 years of experience in the biotechnology and pharmaceutical industries, she specializes in quality assurance for biopharmaceutical manufacturing processes.
Regulatory Compliance and Quality Systems Management
Shirley Fraser possesses extensive experience in regulatory compliance and quality systems management. She has played a key role in obtaining FDA approval for multiple biopharmaceutical products. Her background in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) ensures that quality standards are rigorously maintained.
Mentorship and Industry Involvement
Shirley Fraser actively participates in industry conferences and workshops related to quality assurance and regulatory affairs. She also mentors junior quality assurance professionals and provides training on industry best practices. Her proven track record of improving quality assurance processes and reducing product defects highlights her dedication to excellence in her field.