Summary: Self-motivated professional with 13+ years of experience in regulated Biotech and Pharmaceutical environments. Possesses a strong analytical background with extensive experience in both laboratory and production operations including initial setup/design, laboratory testing, instrument support/ maintenance/qualification, technical transfers and annual product reviews. Extensive experience in the use, design, development, qualification, administration and troubleshooting of both Waters Empower CDAS and Waters NuGenesis SDMS. Superb skills in Computer Systems Validation following GAMP 5, ISO, ISPE and USP <1058> guidelines. High aptitude within various LIMS platforms performed day to day administration of SQL LIMS, assisted in the development of several LabWare LIMS implementations. Top-notch experience in the authoring, review and execution of a wide variety of qualification protocols for analytical instrumentation, CDAS, SDMS, LIMS, ELN and GDMS platforms. Certified LabWare LIMS and Waters Empower Administrator. Excellent project management skills with an unparalleled ability to perform a wide array of responsibilities in a compliant, timely and efficient manner.

Highlights:

• Instrumentation
• Quality
• Quality Assurance
• Quality Control
• Chemistry
• Customer Relationship Management
• Electrophoresis
• Laboratory Instrumentation
• Manufacturing
• Network Support