HE QU (SOPHIE), MS

316-***-**** ac3g0m@r.postjobfree.com

***** ******* ****** ****, ******* Bar, CA https://www.linkedin.com/in/sophie-qu-16291073 Page 1 of 2

SUMMARY

I am a bioengineer with global medical device and pharmaceutical industry experience. I am very self driven, responsible and hardworking person. My expertise includes GxP regulations, process development, project management, data analysis. I am also good at problem solving, trouble-shooting, and cross-functional collaboration.

SKILLS AND KNOWLEDGE

• GxPs: cGMP, GLP, GDP, 5S and ISO 13485 certificate

• Knowledge of Root Cause Investigation tools: 5Whys, Ishikawa Diagram, Pareto Charts

• Cell culture: HEK, Cho cells

• Instrumentations: High Throughput Screening, AKTA Avant/Explorers, Floor/Westfalia Centrifuge, Filter Press, UVP Biospectrum Imaging, High throughput screening

• Applications: Trackwise, SAP, Blue Mountain Regulatory Asset Manager, Ariba Buyer, JD Edwards, Workday

• Software: COMSOLTM, R, Chime

• Microsoft word, Excel, PowerPoint, Visio

INDUSTRY EXPERIENCE

Senior Quality Engineer at Johnson and Johnson, Shanghai, CH April 2017 – August 2017

• Coordinated product recall and stop shipment cases between J&J medical device manufactures and Chinese distributors

• Implemented corrective actions for recall and stop shipment cases in a timely manner, in collaboration with supply chain, regulatory affairs, and marketing. Documented these actions in Trackwise system

• Managed remediation cases in CAPA systems to ensure the cases are appropriately completed and closed

• Revised two quality remediation SOPs to include new Chinese Food and Drug Administration

(CFDA) provisions

• Audited distribution channels to ensure compliance with the regulation Quality Assurance Engineer at Sedecal, Beijing, CH October 2016 – March 2017

• Prepared medical device registration applications to Chinese FDA

• Managed and updated SOPs per Chinese FDA medical device regulations

• Audited suppliers of raw materials and products, such as image panel, X-ray sets for human and animal use

• Liaised with company branches to ensure timely product distribution Engineer I at Baxalta Healthcare, Los Angeles, CA August 2014-December 2015

• Planned and executed pilot scale projects and design of experiment DOE in a timely manner to support manufacture, to maximize product quality and to support process improvement

• Collaborated with manufacture engineers to transfer pilot scales experiment to engineer runs HE QU (SOPHIE), MS

316-***-**** ac3g0m@r.postjobfree.com

21274 Running Branch Road, Diamond Bar, CA https://www.linkedin.com/in/sophie-qu-16291073 Page 2 of 2

• Successfully troubleshot process and process equipment issues

• Investigated incidents, identified root causes, and implemented corrective actions and preventive actions (CAPA); wrote level 1 change control in Trackwise

• Drafted and execute qualification documentation for analytical instrument (IQ, OQ and PQ)

• Worked with cross functional teams on risk analysis in cGMP and non-GMP pilot labs for potential safety hazards prevention and continuous improvement

• Revised Standard Operating Procedures (SOPs) for analytical instrument operation

• Managed a pilot lab using 5S methodology and lean inventory in accordance with industry standards and regulations

• Represented as department liaison in plant Environmental Health Safety (EHS) meetings and department meetings

• Trained and advised laboratory personnel on instrumentation instructions, experimentation techniques

RESEARCH EXPERIENCE

Research Associate at University of California, Riverside January 2015 - Jun 2016

• Collaborated with PhD students to characterized a small molecule compound inhibitor of SUMOylation pathway use High-through put screening technology

• Experienced protein expression in lung cancer cell, CHO cell and HEK cell line Research Assistant at University of California, Riverside January 2012 - March 2014

• Conducted projects on engineer recombinant proteins with various secretion signals to aid in protein expression in mammalian, bacteria and yeast systems

• Collected, documented and analyzed research data sets using statistical analyses; interpreted the results to draw conclusions

• Provided oral and written research data presentations in lab meetings; presented research results in department meetings and scientific conferences

• Collaborated with cross functional group to complete projects on time PATENT APPLICATION

Patent number: BIR20338US00 IR

Modified Hemophilia M Stabilized by Human Serum Albumin Containing No Caprylate and N-Acetyl- Tryptophan

EDUCATION

Master of Science, Bioengineering, University of California, Riverside December 2013

Thesis: Development of Secretion System for Heterologous Recombinant Protein Expression in E.coli Bacteria and P. Pastoris Yeast Systems

Bachelor of Science, Biology, University of Wisconsin, Stevens Point May 2011

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