Kathy Nguyen

Quality Control Chemist II - Precision Dermatology, Inc

DORCHESTER, MA

acd863@r.postjobfree.com - 617-***-****

WORK EXPERIENCE

Quality Control Chemist II

Precision Dermatology, Inc - Cumberland, RI - 2010 to Present

Perform duties according to standard operating procedure in a cGMP environment.

• Analyze physical and analytical testing on in-process, finished, and stability samples.

• Prepare all reagents, standards, samples, process data and related substance.

• Write and update standard operating procedures as well as reports summarize out of specification data.

• Assist in problem solving/investigation related to out of specification/ out of trend results.

• Perform routine equipment maintenance, calibration, and assist in troubleshooting instrument related issues.

• Peer review, compiled data, and HPLC data backup.

• Operate and maintained sophisticate, computer-controlled instrumentation such as, but not limited to: HPLC

(Agilent), ChemStation, Software, FTIR, Karl Fisher, and PH meter.

• Order and maintain supplies.

• Train and Mentor junior chemist.

Senior Chemist

Astrazeneca Pharmaceutical - Westborough, MA - 1996 to 2009

Operated and maintained sophisticated, computer-controlled instrumentation such as, but not limited to: HPLC

(Water, PerkinElmer) EMPOWER, FTIR, AA, UV, Karl Fisher, Oxygen Headspace analyzers, surface tension

meter model 20, viscosity, PH meters, and GC.

• Calculated and verified test data utilizing appropriate regulatory medium i.e. ePMC, LIMS and lab-notebook

assuring that current test methods were followed.

• Tested and reviewed all Quality Assurance Laboratory data to verify that all calculations, chromatography

and other raw data were complete and accurate.

• Performed lab testing using diversified wet and instrumental chemical analyses on raw materials, packaging

materials, finished products, stability samples, or environmental samples.

• Analyzed testing in a manner that is consistent with site-approved as well as federally approved safety

guideline, and regulatory testing requirements.

• Participated in projects to reduce recurring problems and improving lab RFT, through-out the process, and

increase cycle time performance.

• Worked with QA Analytical Services on the implementation of new and/or revised procedures.

• Demonstrated advanced knowledge of methodology/instrumentation using notebooks, LIMS, and CDS while

complying with all compendial and regulatory requirements.

• Drafted reports wrote and performed IOPQ protocols and reports for analytical equipment.

• Trained other staff on new and current equipment and procedures.

• Wrote /updated procedures and Test Methods, and Revised SOP's and CMF's.

• Participated at the QA/Team meetings as well as audits on behalf of the laboratories.

EDUCATION

Bachelor of Science in Chemistry

Simmons College - Boston, MA

1995

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