David Michael Velazco
About David Michael Velazco
David Michael Velazco is a Senior GMP / Validation Specialist at Andelyn Biosciences, with extensive experience in risk management and quality assurance for medical devices. He previously worked at the American Red Cross and holds a Bachelor's Degree in Paper Science and Engineering from Miami University.
Work at Andelyn Biosciences
David Michael Velazco has been employed at Andelyn Biosciences as a Senior GMP / Validation Specialist since 2021. In this role, he focuses on ensuring compliance with Good Manufacturing Practices (GMP) and validation processes. His responsibilities include overseeing quality assurance operations and implementing effective validation strategies to maintain high standards in biopharmaceutical manufacturing.
Previous Experience at American Red Cross
Prior to his current position, Velazco worked at the American Red Cross from 2001 to 2005. During his four years there, he specialized in Change Management and Quality Assurance. His role involved managing quality systems and processes, contributing to the organization's commitment to safety and quality in its operations.
Education and Expertise
David Velazco earned a Bachelor’s Degree in Paper Science and Engineering from Miami University, where he studied from 1980 to 1984. His educational background provides a strong foundation for his expertise in quality assurance and validation processes in the medical device industry. He holds a 6 Sigma Yellow Belt certification, indicating his proficiency in process improvement methodologies.
Risk Management and Quality Assurance Skills
Velazco has extensive experience in risk management for medical devices, particularly in adherence to ISO 14971 standards. He is skilled in implementing Corrective Action Implementation (CAPA) processes and conducting Failure Modes and Effects Analysis (FMEA). His knowledge in these areas supports the development of safe and effective medical devices.
Quality Assurance Operations Processes
David Velazco has a strong background in Quality Assurance Operations Processes, which includes validation and controls auditing. His expertise ensures that quality systems are effectively monitored and maintained, contributing to the overall integrity of manufacturing processes in the biopharmaceutical and medical device sectors.