Cuong (Collin) Tran
About Cuong (Collin) Tran
Cuong (Collin) Tran is a QA Validation Analyst at Octapharma Plasma, Inc., where he has worked since 2015. He specializes in validation efforts for regulated computerized systems and has a background in biology from the University of North Carolina at Charlotte.
Work at Octapharma Plasma
Cuong Tran has been employed at Octapharma Plasma, Inc. as a QA Validation Analyst since 2015. In this role, he leads validation efforts utilizing the GAMP®5 risk-based approach methodology for regulated computerized systems. His responsibilities include developing, approving, and executing validation plans for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. He also reviews validation documents for donor center equipment and assists in the implementation and validation of various computerized systems.
Previous Experience in Laboratory Technology
Before joining Octapharma Plasma, Cuong Tran worked at PCLS in Rock Hill, SC. He served as a Laboratory Technologist from 2012 to 2014 and later as a LIS Interface Specialist from 2014 to 2015. In these positions, he gained experience in laboratory operations and interfacing systems, contributing to his expertise in quality assurance and validation processes.
Education and Expertise
Cuong Tran earned a Bachelor of Science (B.S.) in Biology from the University of North Carolina at Charlotte, completing his studies from 2008 to 2012. His educational background provides a strong foundation for his work in quality assurance and validation within the biomedical field. He is skilled in utilizing Oracle SQL Developer for developing queries to verify system configurations and data integrity.
Validation Methodologies and Responsibilities
In his current role, Cuong Tran participates in project planning, requirements gathering, and risk and impact assessments. He generates deviations, performs root cause analysis, and initiates corrective and preventative actions for technical and procedural issues. Additionally, he trains team members in Good Practice (GxP) regulations, Software Development Life Cycle (SDLC), and Computerized System Validation (CSV).
Regulatory Compliance and Audits
Cuong Tran represents the QA department during meetings and audits related to validation issues, ensuring compliance with FDA and AGES regulations. He provides support for donor centers during audits and contributes to the development and revision of Standard Operating Procedures (SOPs) for validation and regulatory processes. His role is crucial in maintaining the integrity and compliance of systems used in the plasma donation process.