Oklahoma City, Oklahoma, United States
Engineering professional with demonstrated success in project management, manufacturing operations, and process scale-up within a cGMP environment. Extensive experience with writing/revising/reviewing cGMP documents. Fluent in English; conversant in Vietnamese. Specialties: Troubleshooting/Problem Solving, Project Management, Technology Transfer/Scale-Up, Process Optimization, cGMP Operations, cGMP Documentation
Responsible for implementing all stages of the downstream cGMP manufacturing processes, including project management, purchasing, operations, and preliminary review of process documentations for compliance Developed cGMP protocols and SOPs for equipment operations and process validations Drafted and revised cGMP documents: SOPs, Batch Records, Material Specifications, Unicorn 5.0 Process Methods, NCRs Wrote and implemented corrective and preventative measures to prevent nonconformance Led several group training sessions detailing process operations
Developed new datasheets for the top fifteen CEM products for global CEM/client use; implemented by July 2008 Communicated with clients to develop test matrices to troubleshoot nonconformance issues of product