OBJECTIVE
Seeking the position of Senior Research Associate at a pharmaceutical company.
EDUCATION
University of California, Davis
B.S., Biochemistry and Molecular Biology, 2007
EXPERIENCE
IMPAX Laboratories, Inc., Hayward, CA 2008 – Present
QC Analytical Chemist II, Raw Materials Team
• Potency Assays and Impurities testing using Waters HPLC with Waters Empower data acquisition software
• Residual Solvents and Impurities testing using Agilent GC and GCHS with Agilent Chemstation and Dionex Chromeleon data acquisition softwares
• HPLC and GC method validation and current USP method verification
• Analytical method transfer and method optimization
• Troubleshooting, maintenance and calibration of HPLC and GC systems
• Water Content determinations by Karl Fischer Titrations
• Identification by UV and FT-IR
• Particle size by Malvern, Air jet, and Sieve shaker
• Wet chemistry techniques, Loss on dryness, TLC, Residue on Ignition, Loss on Ignition, Heavy metals, Melting range, Viscosity, Specific rotation, and Titration
• Fill in as acting supervisor to schedule testing, release sample, and coordinate with planning
• Write LIR/CAPA reports using Trackwise
• Work with external contract labs to ensure that samples are analyzed and results are reported in a timely fashion
• Implement and follow SOPs, FDA guidelines, and USP procedures in a cGMP regulated environment
SmartQC Project Coordinator at Impax Feb., 2012 – July, 2012
• Coordinated with QC Senior Manager in implementing SmartQC for all QC Raw Materials
• Established database for all Raw Materials testing
• Continuous update and resolve problems on SmartQC for Raw Mat...
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