Li Qiu

ac29id@r.postjobfree.com

Austin area, Texas ***60 512-***-****

Microbiologist

Professional Profile

Substantial experiences in areas of biotech operation, biomedical research and clinical, encompassing both scientific and business aspects

Being extremely reliable, a loyal employee, willing to learn, logical thinker and problem solver

Work Experiences and Skills

ThermoFisher Scientific Inc. 2001 -Present, Austin Texas

Operation Scientist

Planning, performing formulation and quality tests of complicated scientific reagents used on Sequencing and real-time instrument platforms.

Frequently involving in trouble shooting, data analysis and solving problems

Schedule attainment and deliver highest quality product are always my top priority

Ability to work efficiently and independently on complicated processes

Strong organizational, documentation, attention to detail and following up skills

Team work and cooperation, fast paced and progressive working experiences

Maintaining timely and effective communication among team members and cross functional coworkers

Working experience in ISO 13485, CE-IVD, USDA and regulated biotech operation environment

a.Maintaining appropriate documentation to compliance with regulatory guidelines and SOPs

b.Capturing, tracking and escalating quality issues as appropriate

c.Having experiences with ISO audit, internal and external audit

d.Using Track wise to start a PR for quality deviation issues

Technology transferring experiences: 300 million dollar revenue transferring experience

Project Management Experiences: As a member of cross functional new product transferring team, review and edit process documents, formulate and QC test pilot and trial build reagents, set up instruments, bring up process issue and feedback to R&D, perform stability tests

Instrument: Very familiar with Genetic Analyzers, qPCR instruments from Applied Biosystems for manufacturing and QC test purpose.

Perform stability test

Computer and Software: SAP, Track wise, ebuy, Excel, Microsoft word, PowerPoint

Practical Process Improvement experiences

5S skills and experience

Public Speaking experience;

a.As a speak person during a five-day practical process improvement training Kaizen event

b.Team representative at interdepartmental meetings to update team working status

Ambion 1999-2001, Austin, Texas

Research Associate in R&D

Involving in new product development

Baylor College of Medicine 1995-1999, Houston, Texas

Doing biomedical research as a bench work scientist

Education

Medical Science Degree, Medicine Shanghai Second Medical University

(Jiao Tong University)

Professional Development

Company sponsored Professional Development:

Practical Process Improvement 2016

Quality/ Regulatory/EHS Academy 2014

Listening in a Hectic World 2010

Lean Manufacturing Training 2009

Lean Belt Training 2008

Foundation Training, Lean – Six Sigma 2007

Product Commercialization Process training 2006

SAP training 2006

University of Texas at Austin (continuing education) 2007

LEAD THE PEOPLE – MANAGE THE PROJECT

Membership: Society of Clinical Research Associates 2017

Certificates of Attendance from Society of Clinical Research Associates 2017

1.Regulatory Update for Clinical Research Professionals

2.Want to Write a Research Protocol? What to Consider, where to start & How to create a protocol Draft

Completed Online Classes:

Introduction to the Principles and Practice of Clinical Research (IPPCR2016): NIH 2017

1.Overview of Clinical Study Design

2.Design of Epidemiologic Studies

3.Data Management & Case Report Form Development in Clinical Trials

4.Developing Protocols and Manuals of Operating Procedures

5.Quality Management in Clinical Research

6.Clinical Trial Registration and Results Reporting

7.NIH Peer Review Process

8.Study Budget Development

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