* Provided Quality Engineering Validation support for GMP laboratory equipment / instrument (including CSV)* Developed URS & FRS for equipment and instruments* Performed gap analysis on vendor protocols. * Wrote supplemental test srcipts to address vendor and Part 11 compliance gap.* Supported gap/remediation and process improvement initiatives.

* Coordinated the equipment qualification (EQ) and maintenance program* Performed compliance review on relevant EQ documentation.* Performed investigation and assessment on QC discrepancies.* Supported and participated in cross-site lab practice improvement projects. * Mentored junior analysts and provided technical support to lab groups

Research Associate to Formulations Group (2005-2006) * Developed and conducted studies on prototypes and formulation of solid oral dosage forms of small molecules. Coordinated with suppliers and pilot lab for scale-up process. Network System Administrator / Analytical Chemist (2002-2005)* Member of Equipment Maintenance Group in the Analytical Chemistry Group. Performed trouble-shooting and provided technical support to lab equipment-related issues. Maintained all calibration and preventative maintenance records for GMP equipment and instruments.* Agilent ChemStore system administrator to the Analytical Chemistry Group. Trained users and maintained chromatography data system. * Member of the analytical laboratory data system validation project team.Analytical Chemist (1999-2002) * Lead chemist to 2 oral drug programs that subsequently received FDA approval.* GMP/GLP compliance data reviewer for the Analytical Chemistry Group.* Data archivist for the Analytical Chemistry Group. Provide data support during inspections and audits. * Coordinator for outsourced testing - raw material testing, stability study sampling, and method transfer.