SUMMARY OF QUALIFICATIONS Fifteen plus years of experience in Biomedical Research, involving Analytical Chemistry, and Pharmaceuticals utilizing such techniques as Histo-Chemistry, Protein Inhibition, GLP, cGMP, MEIA IMx, Electropheresis, HPLC, Western Blot, Autoradiography, Immunocytochemistry, Electron Microscopy, Fluorescence Microscopy and Inhibition Assay, Anti - Antibodies. Three Years of Medical Education Training and Health care, and five years as a Staff Intern in Allied Health Recruitment. Ten years as Project Manager of multiple Change Control Projects, involved in reviewing Common Process Validation, Review and evaluate validation assessments for IT application systems / projects and Bioassay Lab automation. 21 CFR Part 11, FDA Compliance regulations, FMEA / Risk Analysis and testing experience at Abbott Laboratories. ACHC and HIPAA compliance regulations experience at Coram. Communication skills are excellent with Supervisors, Colleagues and the General Public. Superior attention to details and Identifying issues, form hypothesis design and conduct analyses, synthesis conclusions into recommendations to implement change. Self-starter, disciplined, confident, and goal oriented. Adept in superior written and/or oral presentations to groups of experts. Motivates team members toward common goals and timeline oriented, while adapting to new environments as well as manage and coordinate multiple tasks.

Highlights:

• Documentation
• Management
• Manufacturing
• Compliance
• ISO
• Medical
• Medical Devices
• Policies and Procedures