Background

Ex- FDA Investigator and Compliance officer with experience in Regulatory Affairs and Quality Assurance. Having an expertise in audits and inspections, Mr. Jose has performed over six system inspections of several healthcare companies in the USA and across 25 countries to evaluate firm’s compliances with Title 21, Code of Federal Regulations, the Federal Food, Drug, and Cosmetic Act (the Act), and associated FDA guidelines.

Chronology

2014 – Present

Inspector and Auditor (Virginia)

1987 – 2014

FDA Investigator and Compliance Officer of FDA (Washington D.C.)

Skills

• – GMP
• – FDA compliance
• – Quality Assurance
• – Regulatory Affairs