YIYANG LI Email: acvrqo@r.postjobfree.com Tel: +1-551-***-****

Address: ** ********* **. *** *, Hoboken, New Jersey, 07030 EDUCATION

Stevens Institute of Technology

M.S in Pharmaceutical Manufacturing 08/2014-05/2016 Graduate Coursework: Validation & Regulatory Affairs, Regulation and Compliance in Pharma, Project Management Fundamentals, Good Manufacturing Practice (GMP) in Pharmaceutical Facility Design, and Engineering Economics and Cost Analysis.

Projects:

• Tablets Manufacturing: Used developed formulation to manufacture 3 batches of tablets, including facilities design and choose, flows, production planning, validation, distribution, CAPA and Root Cause Analysis (RCA).

• Build Pharmaceutical Plant: Managed to build a plant, including cost analysis, time. Develop build- ing plan and organized communications and meetings with contractors

• Comparison of EU, Chinese and Japan regulations and guides with US regulations, including FDA Part 211-CFR, Q10, EU Volume 4, Chinese GMP and Japanese GMP Guidelines.

• QA project in Powder Product: Created various sections of ANDAs, amendments and supplements for review. Prepared eCTD. Ensured compliance with all regulations and safety rules. Shanghai Ocean University

B.S in Biological Science 09/2010-06/2014

Undergraduate Coursework: Genetics, Cell Biology, Genomics, Bioinforma cs, Biochemistry, Ichthyology, Auto CAD.

RESEARCH EXPERIENCE

Institute of Neurobiology, Fudan University Study On Retina Immunohistochemistry 07/2012

• Successfully used immunohistochemistry technique to detect antigens in Zebra Fish, Mouse, Rat retina and the these won the Outstanding Graduate Theses. Shanghai Ocean University Study On Regeneration of Lateral-Line air Cells in Zebra Fish 03-06/2011

• The study covered Zebra Fish nurture, lateral-line air cells destroy and regenera on observing. WORKING EXPERIENCE

Roche Internship 8/2015

• Reviewed and compared the Standard Operation Procedures (SOPs) of QC Department with the USA and EU regulations.

• Compared the difference between USA regulations and EU guide for the QC Department.

• Completed and optimized the QC department SOPs with co-workers. Fluor Corpora on Shanghai Internship 05/2015-07/2015

• Organized and checked over 1000 Shenchi Project drawings for the project management and plan- ing. Used Microsoft to input all data into computer and improved all mistakes from drawings.

• Designed and arranged the meter for the Shenchi Project.

• Joined GLOW and arranged two public lectures as the host and made slides for the presentation. Shanghai Media Group Arts and Humanities Channel Internship 01/2014-06/2014

• Participated in the program New Youth as a film editing and director.

• Made more than 80 newsreels and documentaries.

• Participated in the interview of the idols of China’ s got Talent Season V as a film editing. Shanghai Youshun Electronic Technology Co., Ltd Administrative Secretary & Sales Associate Intern- ship 06/2011-09/2011, 01/2012-02/2012, 01/2013-02/2013

• Registered products information and sorted out documents for the production department.

• Tested the functions of the products and their life spans as a Quality Control Specialist.

• Referred to online resources and conducted price comparisons for the promotion of products

• Deal with part of the bank transactions as an assistant of finance manger..

• Market products by B2B Sales and Door-to-Door Sales.

• Taught and trained new interns about sales skills by lectures. Shanghai Ocean University Student Union Liaison Officer 09/2010-09/2011

• Organized students to visit China Maritime Museum and to join public benefit activities.

• Organized School Anniversary Celebrations respectively in November of 2010, 2011 and 2012.

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