Experience manufacturing and technical operations executive with expertise in drugs and medical devices. Accomplished in streamlining operations, maximizing productivity and throughputs, reducing costs, improving quality and regulatory compliance, and implementing innovative technical and operational solutions. Well-rounded, hands-on, and resourceful thinker with the ability to lead, direct, and communicate at multiple levels. Specialties Process Improvements using Six Sigma Methodology and Lean, Statistical Process Control, Process & Computer Validation, Quality Management, 21 CFR Part 210 & 211, 21 CFR Part 820, 21 CFR Part 11, FISMA, SDLC, Project Management, Operations Management, Process Modeling and Optimization, Process Control, Equipment Development and Acceptance, Process Scale-up, Process Startupread more ...read less ...
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