Quality Assurance Engineer

YURIY SHVARTSMAN

***-** ****** ****, #***, Forest Hills, NY 11375

************@*****.***, 646-***-****

OBJECTIVE: To obtain Sr. Chemist position

QUALIFICATIONS:

. PhD in Chemical Engineering and 10+ years pharmaceutical QC and R&D

experience in pharmaceutical and cosmetic products

. Analytical Instrumentation (UPLC, HPLC, HPLC-MS, GC, UV-VIS, FTIR, KF,

TOC, autotitrator), wet chemistry testing expertise

. Analytical instrumentation software (Empower, Totalchrom, Chemststion,

LIMS), as well as Microsoft Office (Word, Excel, etc.)

. 2 years in dissolution equipment installation and USP calibration

experience, IQ/OQ/PQ

. Developed and validated new analytical methods, reviewed and improved

existing analytical methods

. Finished, stability, raw material, in-process testing. Wet chemistry,

LOD, titration, cleaning verification.

. Report preparation; Out-of-Spec result Investigation and reporting;

suggested changes to improve turnaround time

. Excellent knowledge of USP, cGMP regulations, metric system, math

calculations

. Previous years of Chemistry and Chemical Engineering experience, 20+

patents and 20+ publications in scientific journals

. Independent thinker whose analytical chemistry and chemical engineering

enables aptitude for troubleshooting and solving of bottleneck problems.

EXPERIENCE:

Chemist, Suffolk County Water Authority, 09.2012-11.2012 (contract

position)

. Tested drinking water samples using LC-MS/MS

Senior Chemist, A&Z Pharmaceutical, Deer Park, NY, 03.2012-06.2012

. Tested finished and stability products using UPLC and HPLC, FTIR, UV-VIS,

KF, wet chemistry

Senior Chemist, Jerome Stevens Pharmaceuticals, Bohemia, NY, 03.2008 -

09.2011

. Tested raw materials, finished and stability products, in-process samples

using HPLC, FTIR, UV, and KF, autotitrator, particle size and other

methods.

. Reviewed notebooks, testing documentation, chromatograms, transcribed

data, solution preparation's records.

Laboratory Services Chemist, VARIAN Inc., Cary, NC, Nov.11.2005 - 09.2007

. Installed (IQ), verified operation (OQ) of apparatus 1, 2, 3, 7, and USP

performance qualification (PQ) including mechanical testing.

. Completed IQ/OQ for related equipments - autosampler, peristaltic/syringe

pump, filter changer, on-line UV with cell changer or fiber optic,

washing station. Performed preventative maintenance (PM), troubleshooted

and repaired the equipment. Trained customer's chemists, suggested

equipment that could meet customer's requirements. Met and exceeded

customer's expectation.

Sr. Scientist, Chemical Development, BOEHRINGER-INGELHEIM Corp. Richmond,

VA 09.2004 -10. 2005(Temp. position)

. Developed analytical methods for testing synthesized intermediate and

innovative active ingredients

. Maintained and troubleshooted HPLC.

Validation Chemist DEL LABORATORIES, Inc. Melville, NY, 09.2003 - 08.2004

(Temp. position)

. Method Development, Method Improvement and Method Validation of

analytical and cleaning validation methods

. HPLC (Waters Empower) and TOC for pharmaceutical and cosmetic products.

Sr. Chemist, AR&D PAR PHARMACEUTICAL, Inc. Spring Valley, NY, 10.2002 -

07.2003

. Stability Testing of new pharmaceuticals (tablets, capsules) using HPLC,

UV, TLC, KF, wet chemistry techniques.

. Method development; modified methods for testing new and existing

products.

Scientist III, NOVARTIS PHARMACEUTICALS Corp., E. Hanover, NJ, 12.1995 -

08.2002

. Analytical testing finished and stability products (solid, liquid,

capsules) using HPLC, GC, automated, manual and profile dissolution, UV,

IR, TLC, and others.

. Reviewed results for compliance with SOPs, prepared investigation

reports. Troubleshooted instrumentation problems.

. Method modifications and improvements suggested to 20+ methods of

analysis.

. Trained and consulted other analysts on following SOPs, FDA, GMP, and

safety requirements, and using computer applications. Excellent

organization skills, thorough knowledge of cGMP and FDA regulations and

deep understanding of SOP's.

Senior Process Engineer, TECHNOLOGICAL COMPANY, St. Petersburg, Russia

. Managed up to 10 Scientists and Engineers that developed and improved

chemical productions.

. Ensured compliance with current laboratory, manufacturing, safety,

environmental, etc. regulatory requirements.

. Prepared sections to company's quarterly and annual technical reports,

wrote SOP's for analytical laboratories and commercial productions.

Analyzed and generalized results, and composed final reports, prepared

patent applications.

EDUCATION:

Pharmaceutical Quality Assurance Certification, PHARMACEUTICAL QUALITY

CONTROL ASSOCIATION, NJ, 1998

MS in Chemistry, Ph.D. Chemical Engineering, ST. PETERSBURG INSTITUTE OF

TECHNOLOGY, Russia

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