SPDS ERP CVs - DEC 2017

Quanyin Gao Phone: (949) 454-4844 Email: quanying@herbalife.com

SUMMARY • Global quality management and regulatory compliance experience with food (21CFR part110, 114, 117), dietary supplements (21 CFR part111), and pharmaceuticals (21 CFR part 211, 210). • Extensive analytical and microbiological laboratory management experience in cGMP of global regulations on food, dietary supplements, and pharmaceuticals. • 22 + years of working experience in product development and regulatory compliance of pharmaceuticals, dietary supplements, and foods. • USP Expert Committee member on Monograph Development (Chemical Medicine, Monograph 4). EXPERIENCE Herbalife International of America, Inc.. Sep. 2010-present Director ， Quality Control • Directed chemical and microbiological laboratories for RM evaluation, FP development, release, and stability testing using NMR, HPLC, LC/MS/MS, GC, GC/MS, ICP, ICP/MS, NIR, PSL, TL, FTIR, UV, wet chemistry, TEMPO, Solaris, BAM, and PCR. • Nutrition tests (proteins, amino acids, sugar, carbohydrates, polysaccharides, fiber, vitamins, and minerals). • Limit tests (aloins, heavy metals, residual solvents, pesticides, irradiation, TPC, yeast &mold, E. Coli, S. aureus, Salmonella) • Botanical identification with HPTLC, NMR, LC/MS, DNA/PCR • Non-GMO tests with PCR. • Implemented LIMS systems for centralized documentation and efficiency tracking. • Implemented business intelligence tool from LIMS for data based decision making. • Conducted process and stability studies for inner nutrition, cosmetics, and functional food products. Validated cleaning process for chemistry, microbiology, and allergens. • Established chemistry and microbiological lab ISO17025 accreditations. Irvine Pharmaceutical Services, Inc. Mar. 2009-Sep. 2010 Director ， Analytical Development • Managed multiple customers CRO projects to timely deliver results and satisfactory solutions. • Directed bioanalytical tests, formulation and process development (injectable and lyophilized product). • Directed spectroscopic structural analysis and compendial testing. • Directed analytical and bioanalytical method development, validation, and transfer. • Directed drug substance and drug product quality control release tests.

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