Assistant Quality Assurance

Niloufar Mozaffari acr3pv@r.postjobfree.com

* ******** **** #*** ***: 617-***-****

Quincy, MA 02169

Skills Profile

Working experience in Clinical Toxicology Laboratory which specialize in urine drug testing

Certified as “Specialty Technologist” in Chemistry/Toxicology/Pain Management

Working experience with applied spectroscopy and chromatography techniques (LC/MS/MS, GC/MS/MS, GC, HPLC, NMR, IR, and UV)

Working experience with software such as Chemstation, Analyst and OpenLab

Working experience in cGMP, and FDA regulated environment

Generating reports, reviewing data and reporting abnormalities with attention to details

Ability to prioritize tasks and consistently meet deadlines

Fluent in French and Persian

Professional Experience

Lyne Laboratories, Brockton, MA

Analytical Chemist (6/2011-present)

*Support of Analytical method development to support drug substance development and characterization

*Support of method and process validations, stability studies, and special projects

*Operation and maintenance of analytical instrumentation, including HPLC, and GC

*Close interaction with Quality Control and Quality Assurance

*Generate and audit reports to ensure the accuracy of results, keep up-to-date logs, notebooks, charts, and other record keeping devices in accordance with FDA regulations

Calloway Laboratories, Woburn, MA

Analytical Chemist (12/2007-6/2011)-Full time positon

Calloway Labs is a Clinical Toxicology Laboratory which specialize in urine drug testing in the treatment of chronic pain. Calloway is a C.A.P. and CLIA-certified laboratory and holds a Clinical Laboratory License issued by the Commonwealth of Massachusetts.

*Reviewed drug confirmation data from the laboratory, compared with the initial screening data for accuracy and report abnormalities (worked with LIS)

*Operated and maintained analytical instrument such as LC/MS/MS, GC/MS/MS and LDTD/MS/MS

*Worked with ChemStation and Analyst software

*Performed extraction of samples and interpreted results

*Assisted in method development and validation to support drug substance development and characterization

Apredica, Watertown, MA

Analytical Chemist (6/2007-10/2007)

*Operated LC/MS/MS and HPLC to obtain the qualitative and quantitative amount of drugs and their metabolites in plasma and some ADME assays

*Prepared samples for bioanalytical testing and generated reports

TetraGenx Pharmaceuticals, Montreal, Canada

Chemist (8/2006-3/2007)

*Performed physical and chemical testing of pharmaceutical products, using various analytical techniques such as HPLC, UV-visible, Karl Fischer, and dissolution

*Analyzed raw and finished materials under cGMP conditions to assess their purity and stability

*Compiled resulting test data for reporting

McGill University, Laboratory of Polymers, Montreal, Canada

Research Assistant (2003-2004)

*Synthesized and analyzed new conjugated polymers used for electroluminescence devices

Northeastern University, Laboratory of Organometallic materials, Boston, MA

Research Assistant (1999-2002) *Prepared and elucidated the mechanistic path of organic reactions using different bi-palladium complexes

Education

Master in Chemistry (1999-2002) _ Northeastern University, Boston, MA

BS in Chemistry (1991-1996) _ University of Sciences and Technologies, Lille, France

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