I have 20 years of diversified experience in: Auditing (Internal and External for ISO and QSR), Production, Operations, Quality Assurance, Document Control, and Research and Development. Areas of specialized knowledge include FDA, cGMP/GLP, and compliance standards required for pharmaceuticals and medical device, risk management, document control, safety regulations, and working in an Aseptic environment (APA). I am experienced in quality systems in development and contract manufacturing operations. I have excellent communication and interpersonal skills with a proven ability to establish collaborative relationships and able to work as part of a team as well as independently. I have excellent organizational, documentation skills with the ability to prioritize and manage multiple projects and tasks. Finally as a strategic thinker I am able to assess and communicate relative risks to diverse cross-functional teams.
Listed skills include Quality System, Fda, Gmp, Validation, and 35 others.