SPDS ERP Review-May 2015

Teresa Cain 21 New Jersey

Irvine, CA 92606 US Mobile: 949-235-7590 Evening Phone: 949-552-2959 Day Phone: 949-608-3483 Email: teresa_cain@yahoo.com

Work Experience:

Food & Drug Administration ORA/Pacific Regional Laboratory Southwest 19701 Fairchild Irvine, CA 92612 United States

06/2003 - Present

Chemist(Technology Based Expert-Mass Spectrometry) Supervisor : Kim Thomas-Cruse (949-608-2928) •Technical expert in mass spectrometry

•Review of compliance programs and assignments for issuance and implementation •Method Development - caffeine in alcoholic beverages, DMAA in dietary supplements, melatonin in brownies, levomethorphan contaminant in dextromethorphan •Maintenance and qualification of instrumentation and peripheral equipment •LC/MS and DART/MS screening of dietary supplements for drugs •HPLC and LC/MS analysis of components of dietary supplements, such as unapproved drugs, aristolochic acid, weight loss and erectile dysfunction drugs and analogues •LC/MS analysis of drugs and medical devices •LC/MS screening of food samples as part of the Food Emergency Response Network for counter-terrorism •Presentations at AOAC and ASMS National meetings •Review of private laboratory packages for technical merit and evidence of compliance •Participation in national calls for work coordination with headquarters divisions and other field offices •Training of personnel in laboratory analyses and quality control •Member of Course Advisory Group for Basic Mass Spectrometry •Inspection of regulated industry for GMP compliance Quality Control •Review of Analytical Worksheets for quality and technical merit •Review and trending of data for quality control •Writing Lab-wide SOPs for Method Validation, Quality Assurance and Instrumentation and QA instrument qualification for HPLC and LC/MS. Details: •Acting Import Compliance Manager •Acting Import Compliance Officer – Non-Foods (cosmetics, dietary supplements, devices) •Acting Chemistry Branch Director

Ribapharm (ICN Pharmaceuticals) 3300 Hyland Ave Costa Mesa, CA 92626 United States

10/2001 - 06/2003

Scientist •High throughput parallel purification for combinatorial chemistry libraries. •Method development purifications of challenging compounds •Quality assurance LC/MS analysis of novel drugs in support of synthetic chemistry department. •Supervision of associate level chemists/scientists

Cortex Pharmaceuticals 7700 Irvine Center Drive Suite 750 Irvine, CA 92618 United States

08/1999 - 10/2001