Functional Skills
Quality Assurance
Good Manufacturing Practice (GMP)
Regulatory Compliance
Software Skills
Microsoft PowerPoint
Microsoft Excel
Microsoft Word
Sector Experience
Life Sciences & Pharma
Fortune 500
Experience
Regeneron Pharmaceuticals
Research
Senior Quality Assurance Validation Specialist
11/2015 - Present
• Analyzes and evaluates summary reports for the qualification of equipment and processes using a strong knowledge of governmental and regulatory requirements.
• Recommends and assists in the implementation of corrective actions and procedural improvements.
• Trains newly hired employees on review of quality control, facilities, and validation reports.
• Recommends and assists in the implementation of corrective actions and procedural improvements.
• Trains newly hired employees on review of quality control, facilities, and validation reports.
Regeneron Pharmaceuticals
Research
Quality Assurance Validation Consultant
5/2013 - 7/2023
• Reviewed executed protocols for the testing of controlled temperature units.
• Authored summary reports for the assessment of qualification states.
• Assessed analytical reports for accuracy and validity of results.
• Authored summary reports for the assessment of qualification states.
• Assessed analytical reports for accuracy and validity of results.
Dr. Reddy's Laboratories
Research
Quality Assurance Validation Consultant
2/2013 - 5/2013
• Reviewed laboratory notebooks for scientific and documentation errors.
• Authored standard operating procedures for use by analytical chemists.
• Calibrated equipment for use in laboratories.
• Authored standard operating procedures for use by analytical chemists.
• Calibrated equipment for use in laboratories.
Albany Molecular Research, Inc.
Research
Regulatory Affairs Assistant
2/2008 - 4/2012
• Drafted portions of Drug Master Files, which helped to meet FDA requirements.
• Researched commercial laboratory products and wrote Annual Product Reviews.
• Researched commercial laboratory products and wrote Annual Product Reviews.
Albany Molecular Research, Inc.
Research
Research Scientist I, Stability and Quality Control
1/2005 - 2/2008
• Conducted HPLC experiments to evaluate the stability of pharmaceuticals.
• Authored stability protocols to assess the stability of compounds.
• Authored stability protocols to assess the stability of compounds.