Medical Assistant Quality Control

Shuwei Li

** ********* **. ***** **** ON M*H *K4 Canada Phone: 647-***-**** Email:***.*****@*****.***

CAREER OBJECTIVE

Seeking a QC Chemist or an Analyst position in pharmaceutical or cosmetic industry where I can apply my expertise and effectively contribute to the organization’s growth.

SUMMARY OF QUALIFICATIONS

• MD in medicine with over ten years of experience in medical and pharmaceutical research.

• Experience in HPLC, UV-Vis spectrophotometer, FT-IR, Dissolution, GC, TLC, Carl-Fischer.

• Sound knowledge cGMP, GLP, GDP and departmental SOPs.

• Familiar with USP BP/EP and FDA ICH regulations.

SKILLS

• Ability to apply knowledge and skills of transferable, rapid adaptable and quick learnable.

• Ability of HPLC purging, conditioning, Chromatogram analyzing, integration and troubleshooting.

• Ability to use a LIMS system to report data.

• Ability to follow protocol to perform Potency Assay, Content Uniformity and Impurities testing by HPLC.

• Excellent communication skills including research writing skills and bilingual with fluent Chinese.

• Computer proficient in MS word, Excel, Internet, Empower and Chemstation.

• Perform HPLC, FTIR, UV/Vis, Dissolution, TLC, KF titration, or other wet chemistry techniques as instructed.

• Knowledge to follow FDA, GMP guidelines, company SOP’s to establish test methods.

• Ability to perform laboratory analysis on incoming raw materials, in-process samples, finished products and stability samples.

• Prepare samples, standard and reagent including buffers, mobile phase, diluents for chromatographic analysis.

• Record test results accurately, neatly and promptly in Lab Notebook following each test.

• Support projects as directed that lead to technical studies of the manufacturing processes

• Ability to conduct quality control routine and non-routine analysis of raw materials, in process, and finished products according to standard operating procedures.

• Value collaborative work environment with demonstrated ability to function as a team player.

• Good interpersonal skills and a proven ability to work with people of differing levels.

• Tremendous protocol management and data collection and methodology including use of internet technology..

• Ability to accommodate a flexible work schedule and ability to travel.

• Strong background in Physiology, Anatomy, Pathological Anatomy and Biochemistry.

• Excellent organization, planning and problem solving abilities.

PROFESSIONAL LICENCES AND CERTIFICATES

Diploma of Pharmaceutical QC/QA. Pharmaceutical Science College of Canada

ARDMS Ultrasound Obstetrics & Gynecology License

ARDMS Ultrasound Abdomen License

Certificate in CT, MRI scan, the Chinese Medical Association

EDUCATION AND PROFESSIONAL AFFILIATIONS

MD Doctor of Medicine, Hebei Medical University China

Professional Member, the Chinese Medical Association

Shuwei Li

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33 Tuscarora Dr. North York ON M2H 2K4 Canada Phone: 647-***-**** Email:***.*****@*****.***

PROFESSIONAL EXPERIENCE

Medical Assistant, Pharma Medica Research Inc. 2009-2010

Ensured accuracy and legibility of study files according to protocols and regulations.

Assisted in the review of study files upon data entry at check-in, on-study and post-study clinical trial procedures.

Performed subject interviews to obtain blood/urine samples, ECGs, vital signs, height, weight and frame size.

Reported adverse events, irregularity or non-compliance that occurs during the study.

Medical Assistant, Biopharma Services Company 2008-2009

Performed technical and administrative functions including medication administration under physician’s directions as required by the protocol and in accordance with implementing procedures.

Conducted the Inform Consent process and provided ongoing communication of study information to subjects.

Ensured subjects are efficiently monitored and that safety requirements are implemented.

Performed specimen labeling, copying, numbering, and archival of project and supporting documentations.

Professional worker, Department of Foam and Glue, Global contract. 2006-2007

Sprayed blue to the fabric and pasted it to the foam.

Senior Doctor Department of Medical Imaging, First Hospital of Hebei Medical school 1995-2005

Weekly classroom teaching and lab supervision of operating, mending and maintaining of equipments including CT, MRI, and X-Knife.

Specialized in cancer early stage diagnosis using needle biopsy under Computed-Tomography (CT) or Ultrasound guidance in suspicious mass for pathological and cytobiology study and cancer research.

Performed Magnetic Resonance Imaging (MRI) examination using magnevist solution contrast to diagnose tiny brain stem glioma.

Cured many patients with lung, liver, kidney, pancreatic cancer and brain stem tumor using X-knife treatment.

Performed MRA and MRV measurement of Brain Willis Circle Aneurysms and A-V Malformation and X-Ray Liner Accelerator (X-Knife) treatment.

Surgeon, Department of Surgery, Hebei Fuping Hospital 1990-1994

Performed general surgical operation including stomach, kidney, breasts and colon cancer removal.

Responsible for evaluation of tissues after operation and provided interpretation and expert advice to related pathology issues

Surveillance of aseptic sterilizing work in operation room, tissue culture room, and dressing change room.

Emergency treatment including Trauma, swelling caused by cranium trauma, with thoracic-abdominal and limbs trauma and achieved speedy recovery.

References are available upon request.

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