Senior Consultant, Biologics Consulting Group, Inc.
Oviedo, FL

Jun. 1995 – Jul. 2009

Consumer Safety Officer/Investigator. FDA, Florida District Office.

• Plan and routinely perform inspections in the areas of Blood, Plasma, Human Tissue Products, Dietary Supplements, and Bioresearch Monitoring (BIMO), to ascertain compliance with Good Manufacturing Practices, Federal Regulations and the Food, Drug & Cosmetic Act;
• FDA Level II Biologics Certified since June 2002;
• Conduct Special Request Investigations;
• Manage the FLA-DO Dietary Supplement & Internet Surveillance Programs by planning, prioritizing and assigning work;
• Routinely serves as a FLA-DO trainer for Biologics and Dietary Supplement programs using On-the-job training or Class lecture for new employees;
• Numerous speaking engagements at various FDA sponsored classes and workshops.

Jan 2005-Apr 2005, Jan 2002-Apr 2002

Supervisory Consumer Safety Officer Detail, FDA

• Plan, prioritize, assign, and review work of a staff of six (6) Investigators which includes inspectional and investigational activities in all regulated program areas including Foods, Drugs, Biologics, and Dietary Supplements;
• Evaluate the inspectional reports of Investigators to determine appropriate regulatory action based on inspectional findings;
• Evaluate Employee performance using written work or on-site inspectional activities;
• Implemented the FLA-DO New Hire Training and Mentoring Program;
• Duties as described in the above current detail listing.

Consumer Safety Officer/IND Reviewer, FDA, CBER. Rockville, MD.

• The Regulatory Member of the Vaccines Branch Regulatory Review team, with the responsibility of reviewing of all incoming Investigational New Drug Applications (IND’s) and supplements for compliance with 21 CFR 312, and initiation of appropriate regulatory action.