Mary Lynden Dominguez
MS Regulatory Affairs
My name is Mary Lynden, and I am an accomplished quality and regulatory professional with over 15 years of experience in CLIA-certified, CAP-accredited laboratories. I possess a comprehensive understanding of laboratory requirements set by state, federal, and accreditation agencies, as well as expertise in Quality Management Systems and Regulatory Frameworks.
Experience
Quality Assurance, Regulatory Affairs, Laboratory Licensing and Accreditation, High-Complexity Testing, Project Management, Laboratory Information Systems, Quality Management System, Laboratory Developed Test
Certifications and Licenses
ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
Six Sigma Green Belt
California Laboratory Scientist, Generalist
Medical Laboratory Scientist (ASCP)
KEY ACHIEVEMENTS
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Successfully managed and directed quality assurance activities for a CLIA-certified, CAP-accredited laboratory. Implemented robust quality management systems and ensured compliance with state and federal regulations.
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Recognized for significantly improving laboratory quality standards and achieving high ratings during accreditation audits.
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Successfully led the implementation of a Quality Management System in a CLIA-certified, CAP-accredited laboratory.
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Spearheaded a major laboratory accreditation process, resulting in a significant reduction in non-conformities.
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Developed and conducted training programs on regulatory compliance and quality assurance for laboratory staff.
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Successfully managed quality assurance projects that improved laboratory efficiency and reduced errors.
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Recognized for outstanding performance in laboratory inspections and audits by state and federal agencies.
