Experience

• 

  DDP Medical Supply

  • St. Petersburg, FL

  • Certified Designated Representative/Regulatory Compliance Manager

    • Dec 2008 - Oct 2019
    • St. Petersburg, FL

    * Examine, select, order, and purchase at the most favorable price pharmaceuticals consistent with quality, quantity, specification requirements and other factors.* Receive and store incoming pharmaceuticals, verify quantities against invoices and check for outdated pharmaceuticals in current inventory.* Receive and pass all transaction data (statement, information and history) for all inbound and outbound pharmaceutical items. Quarantine all pharmaceuticals through entire verification process.* Maintain proper temperature and security conditions for pharmaceuticals.* Create and maintain files for each customer and vendor, including due diligence paperwork and verifying license and address information is current.* Create and maintain pharmaceutical policy and procedures. Implement change control process when revisions are made or suggested. Document change request, initial assessment, implementation and final assessment.* Primary contact for all FDA, DEA, and state inspections.Software: Microsoft Office (Word, Excel, PowerPoint, Access, Outlook), AS400, PeopleSoft, Adobe Photoshop and Illustrator, MAS 90 and 200, Macromedia (Dreamweaver, Flash and Fireworks) Word Processing: 70 wpm, 100% accuracy. 10-key by touch: 16,000 ksph.Familiar with the following pertaining to state and federal drug laws:Drug Quality and Security ActDrug Supply Chain Security ActFlorida Statutes – Chapter 499 (Florida Drug and Cosmetic Act)Florida Administrative Code – Chapter 61N-1 (Regulations for Drugs, Devices and Cosmetics)Code of Federal Regulations – Title 21 – Food and Drugs (Parts 210 & 211- cGMP for Drugs and Finished Pharmaceuticals)21 United States Code – Subchapters 321 (Definitions), 331 (Prohibited Acts), 333 (Penalties), 351 (Adulterated Drugs and Devices), 352 (Misbranded Drugs and Devices), 353 (Exemptions and Consideration for Certain Drugs, Devices and Biological Products)