Dedicated Supervisory Consumer Safety Officer with a strong background in employee and program management, effective communications in high priority situations, employee development, and FDA/ORA procedures.
Sound judgment and decision making
Workforce and program planning
Exceptional organization skills
Strong interpersonal skills
Excellent oral and written communication skills
Consumer Safety Officer, 10/1996 to 11/2001 Food and Drug Administration – 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054
Conducted inspections, mostly in the biologics and medical device areas.
Reviewed records and observed operations at regulated firms, documented deficiencies, obtained voluntary corrections where possible, completed written reports, recommended further regulatory actions as needed.
Inspections resulted in many voluntary corrections, several Warning Letters, one Notice of Intent to Revoke, one License Revocation, and one Licence Suspension.
Provided training and on the job training to other Consumer Safety Officers.
Consumer Safety Officer/Biologics Specialist, 11/2001 to 05/2002 Food and Drug Administration – 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054
Conducted complex inspections of blood bank and human tissue facilities.
Supervisory Consumer Safety Officer, 05/2002 to Current Food and Drug Administration – 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054
Direct and advise Consumer Safety Officers (CSO's) on inspectional and investigational work activities in the food, drug, biologics, BIMO, and medical device areas.
Advise and direct CSO's to collect appropriate documentation in order to establish violations of marketed products, assess the hazard to public health, and determine whether recall or further regulatory action is needed.
Review, edit, and approve written work products. Coordinate information with the Director of Investigations Branch (DIB), Compliance Branch, the District's Recall Coordinator, and others, as appropriate.
Evaluate employee performance, including mentoring, writing performance reviews, award nominations, promotion justifications, etc.
Organize and coordinate District cadre meetings and other training. Write justifications to fund district training. Coordinate District nominations for DHRD training courses.
Participate in the development and revision of Standard Operating Procedures.
Work with other government agencies as needed, including NJ state and local health departments.
Developed and implemented the District's New Hire Training program.
Participated in various audits, including an IOG recall audit, EU audit, and internal QMS audits.
Monitor the district's Biologics and BIMO work plans, including creating assignments, issuing them to other groups, monitoring completion, resolve questions and problems, etc.
Disseminate high priority work assignments to groups within the district. Provide secondary review of written work products that will be further reviewed by Compliance Branch for regulatory action.
Acting DIB for New Jersey District on numerous occasions. Acting Assistant to the DIB since July 2014.
Bachelor of Science: Medical Technology, 1996 Salisbury University - Salisbury, MD