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Recent CWRU graduate - MA in Bioethics, Clinical Research Concentration. Experienced Regulatory Affairs/Compliance Specialist (FDA, DOI, NIH, OIG, OSHA). Extensive knowledge of IRB processes, including SpartaIRB Protocol. Assisted in several CWRU IRB quality improvement and review processes. Proficient in education/training methods and electronic presentations. Extensive experience writing and monitoring policies and proce...
SUMMARY Professional with over twenty five years of broad-based experience in risk management ensuring that the health and safety of employees, the public, and the environment are maintained to the strictest of standards by taking a proactive, rigorous, value-added approach employing strategic vision and innovation while practicing fiscal stewardship. Undertakings include laboratory, facility and manufacturing regulatory co...
Tags for this Online Resume: ISO, Management, Program Manager, Quality, Quality Assurance, Quality Management, Manufacturing, Risk Management, Distribution, Integrate, Root Cause, Compliance, Corrective Action, Safety, Environmental, 14001, Team, EHS, GMP, Laboratory, Leader, Pharmaceutical, Biotech, due diligence