Mayra Gonzalez

***** ***** ******* * ***.*** Miami Lakes, FL 33014

201-***-**** acrm8l@r.postjobfree.com

Summary: Senior Chemist with over 15 years of practice in the pharmaceutical manufacturing industry. Motivated for a new career challenge in order to use my skills and continue acquiring knowledge.

Education: Masters in Biochemistry - University of Havana - Havana, Cuba - July 1984

Instrumental Analysis Expertise: HPLC, GC, TLC, UV, FTIR, Viscometer, Karl Fischer, Polarimeter, pH/Conductivity Meter, Penetometer, Refractometer, Wet Chemical Techniques

Skills: Microsoft Office, Excellent knowledge of Pharmaceutical Analysis, Quality Control/Quality Assurance, Current Good Manufacturing Practices

Experience: Stratus Pharmaceuticals, Miami Gardens, FL

Quality Control Manager 2013- Present

Coordinated the stability program of finished dosage forms as per cGMP and FDA compliance

Supervised the laboratory controls and compliance for the release or rejection of API Raw Materials, In-Process, Finished Dosage Forms, and Stability Samples while adhering to USP or In-House testing methods

Conduct the validation of compendia testing methods including creation of company standard operating or testing procedures

Responsible of leading the quality control unit, assigning projects to analysts, replenish inventories, keeping up to date data records as well as calibration records of instruments that include HPLC, GC, UV, FTIR, Analytical Balances, Thermometers, Viscometers, Refractometer, pH/Conductivity Meters, Ovens, etc.

Sonar Products INC., Carlstadt, NJ

Biochemist, January 2000-2013

Perform analysis of Raw Material, In-Process Product, Finished & Stability Products, by USP/NF, FCC, BP & In-House test methods, using GC, HPLC, UV, FTIR, Wet Chemistry, etc.

Calibrate & maintain laboratory equipment, ensure compliance with cGMP and FDA regulation

Prepare test reports & maintain test records

Evaluate data to determine eligibility for release of Raw Materials/Bulk products to the manufacturing/packaging process

Perform every year the annual review of the company, analyzing the Raw Material for Vendor Certification

Maintain inventory of stability samples & reference standards

Sugar Cane Research Institute, Havana, Cuba

Biochemist Researcher, 1985-1996

Performed mineral, nutrition, and chromatographic techniques

Performed Wet Chemistry-Titration, pH, sample preparation, set up of methods for establishing product identity

Developed techniques for the analysis of sugar cane leaves and stem

Set up electrophoresis & chromatography techniques for the research of sugar cane variety & the improvement of sucrose production

Developed quantitative determination of pigments & enzymes, protein purification & development of diagnosis method

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