Project Quality Control

Y ing Lu

**** **** ***, **** *, Sunnyvale, CA ***86 909-***-**** y ****@******.***.***

Highly motivated individual with combination of specialized knowledge and laboratory experience in

pharmaceutical and biotech areas. Earned a Professional Science Master’s degree and a Food Science

Master’s Degree with i nterdisciplinary t raining in Pharmaceutical Discovery and Development,

Regulatory Affairs, etc. I’m looking for a regulatory position in a pharmaceutical/biotech company.

EDUCATION

Master of Bioscience (MBS) D ual Focus: Pharmaceutical Discovery & Development, Clinical &

Regulatory Affairs

Keck Graduate Institute, Claremont, CA A ugust 2009-

December 2011

Master of Philosophy in Biology (Emphasis on Food M icrobiology & Chemistry)

T he Chinese University of Hong Kong, Hong Kong SAR, China A ugust

2005-April 2008

Bachelor of Science in Biological Science

Beijing Forestry University, Beijing, China September

2000-July 2004

PROFESSIONAL EXPERIENCE

QA and Regulatory Specialist

October 2010- Jul 2013

AuNutra Industries, Inc.

• Analytical method (HPTLC, GC/MS and HPLC) development, validation and application

• Collect and prepare core scientific information and safety studies for ingredients that are seeking

FDA/self-affi rmed GRAS Status or ND I

• Provide regulatory guidance on cGMP requirements for facility/product/personnel/documentation,

product health claims for marketing/labeling/packaging, on organic requirements, i r radiation

requirements, pesticides requirements, new product development, etc.

• Draft SOP for company’s quality control workflow

• Establish company’s Suppliers’ Qualification Program

• Support and assist the company for customers’ GMP audit

• Review batch records

• Coordinate lab analysis of the products and interpret of the test results to cross-functional

departments and customers

• Inspect quality of dietary supplements raw materials and corresponding ingredients against

specifications and quality standards before release

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Y ing Lu

1107 Reed Ave, Unit B, Sunnyvale, CA 94086 909-***-**** y ****@******.***.***

• Investigate root cause of product test failures and product returns, implement corrective and

preventive actions

• Prepare products and safety documents for the release ingredients

Research Assistant J uly 2005-

January 2008

Laboratory of Food M icrobiology and Food Flavor, The Chinese University of Hong Kong

• Designed and conducted experiments on food f lavor analysis by using GC/MS etc. techniques and

evaluated the results, including sensory analysis.

• Independently finished the research project, “Survey on Commercial Sufu (Fermented Soybean) and

Optimization of the Model Sufu Production”.

GRADUATE ACADEMIC PROJECTS

Graduate Consultant, Team Master Project for Allergan “Performance Testing and Economic

Feasibility of

Disposable Fermentation Technology for M icrobial Systems”

Sep 2011- Dec 2011

• Performed PFD, P&ID drawing for bioreactor equipment system connection and installation

• Designed SOPs and Testing protocols for microbial expression systems growth in bioreactors

• Participated in bioreactor equipment system installation, Media preparation & bioreactor equipment

function

• Evaluated the bioreactor system by wet testing

• Financial and cost analysis of the evaluated bioreactor system

• Data analysis of the testing results

• Manage project progress by using project planning tools such as GANTT charts, work breakdown

structures, RAM chart, etc.

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