Experience

DPT Laboratories

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Regulatory Affairs Specialist

  • Aug 2016 - Sep 2017

  San Antonio, Texas Area Regulatory Specialist mainly responsible for submitting company Annual Reports and assisting in compiling and writing sections for ANDA filings to FDA and entering key submission information into a company data base for management use.



Palm Beach Parma Corp

• Pharmacy Technician

  • Mar 2015 - Aug 2016

  West Palm Beach, Florida  Prepared prepare diabetic testing supplies for patients  Stocked all supplies for the pharmacy  package all diabetic testing supplies for shipment to patients  prepare compounded diabetic vitamins for patients  prepare compounded creams designed for diabetic patients  order all compounding supplies and chemicals for pharmacy



Perscriptions Plus

• United States
• Hospitals and Health Care

• Pharmacy Technician

  • Jun 2014 - Feb 2015

  Wellington , Florida Prepared prepare diabetic testing supplies for patients Stocked all supplies for the pharmacy package all diabetic testing supplies for shipment to patients prepare compounded diabetic vitamins for patients prepare compounded creams designed for diabetic patients order all compounding supplies and chemicals for pharmacy



DS Laboratories Inc

• Manager Regulatory Affairs

  • Aug 2013 - Apr 2014

  Pompano Beach, Florida Prepared all regulatory documents for the company’s cosmetic products so they can be exported to foreign countries. Update product labeling to comply with US and foreign country requirements. Advise formulators of restrictions on the use of ingredients and use levels as mandated by foreign countries so that they comply with regulatory requirements. Supply all required regulatory shipping documents required by foreign customers so products can be imported into the desired… Show more Prepared all regulatory documents for the company’s cosmetic products so they can be exported to foreign countries. Update product labeling to comply with US and foreign country requirements. Advise formulators of restrictions on the use of ingredients and use levels as mandated by foreign countries so that they comply with regulatory requirements. Supply all required regulatory shipping documents required by foreign customers so products can be imported into the desired country. Updated all of the company’s product material safety data sheets to comply with current US and international standards s well creating technical data sheets for all products to be used as standards for product certificates of analysis. Show less



Palm Beach Gardens Medical Center

• Pharmacy Technician

  • Apr 2013 - Aug 2013

  Palm Beach Gardens , Florida Prepared Chemotherapy and IV medication for patients Stocked Pixis medication stations Delivered stat medications and narcotic medications to floor units Delivered patient specific cart fill medications to designated hospital units.



Actavis plc (now Allergan)

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Coordinator

  • Aug 2007 - Feb 2013

  Sunrise, FL Prepared ANDAs, amendments, and supplements for submissions to the FDA Responsible for publishing all eCTD submission associated with the site Contacted and scheduled testing location with established and new CROs for bioequivalence studies for new drug products under development Coordinated the acquisition of labeling information for ANDA submissions



North Broward Hospital District

• Regestered Pharmacy Teachnician

  • Jul 2004 - Apr 2010

  Fort Lauderdale, FL Prepared Chemotherapy IV medication for patients Prepared IV medication for patients Stocked Pixis stations Prepared special compounded medications



Able Laboratories Inc.

• Regulatory Affaris Associate

  • 2002 - 2004

  Cranbury, NJ Prepared ANDAs for submissions to the FDA Prepared information for submissions to various states formularies Reviewed specifications and methods for finished products, Intermediates, and raw materials Reviewed product labeling, validation summary reports and product stability reports



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Technical Writer

  • Jan 2002 - Mar 2002

  Branchburg NJ Wrote technical reports to support company testing methods and equipment Wrote company SOPs for new testing procedures



Labcorp

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Laboratory Technician

  • Feb 2001 - Dec 2001

  Raratin , NJ Prepare and ran medical laboratory specimens for analysis utilizing chemistry analyzers. Review data and release results over computer system



Convatec

• United Kingdom
• Medical Equipment Manufacturing
• 700 & Above Employee

• Formulation Chemist

  • Aug 1998 - Mar 2000

  Skillman, NJ Formulation development and stability testing of topical OTC drug products and personnel care products for institutional and long tern care facilities Product formulation development for the company that were compatible for European and South American markets Wrote study protocols for new and current company products to support product label claims