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QC Analytical Chemist

Bayonne, NJ
November 08, 2018

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Associate Scientist

David Drzewiecki (H) 201-***-**** ● Page 1


Pharmaceutical Analytical QC Scientist with ten plus years’ experience in R & D, QA and QC duties, CRA training. HPLC, UPLC, GC, Empower2 and 3, GLC/GCP/GMP.Completing 4th year of NJCU Chemistry BS with few classes left, seeking return to career work for a great corporation.


Returned to college to finish the BS in Chemistry

Acquired NMR, LC/GC-MS, Fluoro, Electrochemistry, Ramen Spectro, Surface Absorption skills

Improved MD in developing AIDS and Asthma investigational drugs by troubleshooting experimental SOPs

Implemented nicotine method transfer from dissolution USP method 2 to biodis USP 4

Conducted critical analysis of experimental sample impurities for root cause of problems

Coordinated QA CA/PA Trackwise Pseudophrene investigations

Reduced by 66% the dissolution and LC testing time of multiple nicotine consumer products

Combining earlier nursing and radiography clinical coursework with current CRA training


New Jersey City University, Chemistry BS completion in 2019

Aurolife Lay-off after 10/12, Return F/T to NJCU in 1/15 under NJ Tuition Waiver Program-Now must return to work F/T after corporate cuts to wife’s salary

Clinical Research Associate Certification, American Institute of Pharmaceutical Technology

Indiana University/Thomas Edison State College/Owens Technical College Rad Tech/Nursing

National Healthcare Association; Fairfield, NJ; MLT, Phlebotomist

Ohio Army National Guard; 612th Engineering Battalion, Ohio; Water Technician


Clinical Research Associate Certification, American Institute of Pharmaceutical Technology 03/11

Aurolife, Dayton, NJ 11/10-10/12

Associate Scientist

QC HPLC, Dissolution, KF, FT-IR studies on Class I-V API and Controlled Drugs, Raw Materials to Stability Products: GXP, HPLC, GC, Empower2 and 3

Population Council, NY, NY 11/09

QC HPLC Dissolution Chemist

Facilitate R & D SOPs, HPLC, UPLC, Contraceptive Formulations, HPLC, Dissolution, Empower 2 and 3

PolySystems, Bayonne, NJ 8/09

Temporary GC Raw Materials Analyst

Maintain Analysis of Raw Material and Finished Products

Gibraltar Laboratories, Inc., Fairfield, NJ 6/08 - 8/08

QA Calibration Manager

Supervise PM, IQ, OQ and PQ Lab Instruments; Manage and Improve SOP Documents

Schering-Plough, Inc. /Merck, Summit, NJ, GMP Labs 1/07 - 2/08

QC Analytical Scientist I

Perform LC/GC Assay and Stability Studies, Degradants, Residual Solvents, Phase II Drugs; Notebook Review: HPLC, GC, GMP, Empower 2

GSK, NDP Department, Parsippany, NJ 6/04 - 12/06

QC Junior Scientist Consultant

Nicotine Assays ; In-Process, Stability and Raw Materials Testing For OTC, USP and NF Solid and Semi-Solids ; HPLC, GC, GXP, Empower 2 and related systems


Associate Scientist

David Drzewiecki (H) 201-***-**** ● Page 2

CasChem Inc, Bayonne, NJ 3/04 - 6/04

QC Analytical Chemist

Prepare COA’s on Castor Oil Derivatives and In-Process, Finished Product on ASTM MSDS Testing with wet chemistry

American Institute of Pharmaceutical Technology, Hackensack, NJ 9/03 - 3/04

Raw Materials QC Chemist

Perform Compendial Studies on Contract Pharmaceutical Samples, GC, HPLC

Parmalat; USA; Wallington, NJ 3/01 - 4/03

QC Food Analyst

Conduct FDA and HACCP Food and Water Bioassay Testing in Fast-Paced GMP Lab and Plant Operations


LC/MS, NMR, Ion Chromatography, HPLC, UHPLC, FT-IR,uV-VIS, AA, TLC, Solid and Capsule Dissolution USP Methods 1-5 Profile Testing Controlled Drug Substance Documentation, Product, OTC, API and CS, Class I-IV Drugs; Raw, Intermediate, Finished and Stability Products; MV, MD, MT, Phases I -IV Investigational Drugs, Chiral/Achiral, Diasters, Enantiomers, Residual Solvents, Assay, Blend Uniformity, Content Uniformity, Cleaning Studies, Assays, Degredations, EA, KF, Titration, Conductivity, Friability, Hardness, LOD, LOI, TOC, DT, ID, RI, SG, MP, Ref Standards Recertification, Wet Chemistry, OTC, Volatiles, Acid Values, Sample Distribution and Reconciliation

CRA, PM/IQ/OQ/PQ Lab Equipment Maintenance, Calibration, Troubleshooting, COA, SOP Technical Writing, QC Document Management, SOP and QA Lab Notebook Review Investigations Empower 2 and 3, Atlas, LIMS, ChemStation, Millennium 32, El Dorado, TrackWise, Andev, Dissoft, Documentum, Saba, MS Office/XP/7; FDA 21 CFR parts 210-211, cGMP, GxP, USP32, NF27, EP, USP, NF OSHA, CAPA, OOS, OOT, Certifications, Deviations, Change Control, EHS, LIMS, EPA, DEA, HACCP, Microsoft Office

Agilent 2695D 1100 with 2487 UV-Vis Detector PDA, Agilent 1200, Perkin-Elmer Series 200, Shimadzu 1200/ 2010, HP Series 1050; HP 6890, Agilent 5890, PE Spectrum Clarus 500, Distek 1200, 5100 and Evolution 4300, 6100; VK7000 Biodiss Bath; Hansen SR8 Diss Bath, PE Spectrum 100 FT-IR, HP IR Vectra 486/33N; Shimadzu 210 uV-VIS, Agilent 8453, Horba Polarimeter SEPA-300; VK100 DT, 2400 Series II CHNS/O System EA; Shimadzu AAFE Model 660, AA Varian Spectra AA 250 Plus K; Rudolph An. Res. A20767 Autopol Automatic Polarimeter, pH, Orion Ion Analyzer EA940


NJCG Chromatography: New Techniques and Applications


NJCG Waters HILIC-LC-MS Conference

Restek GC-MS Training Seminar

Agilent Technologies ’09 GC-LC Tips and Tricks Tour

Waters Efficiency Method Development and Validation Seminar


North Jersey Chromatography Group

Chromatography Forum of Delaware Valley

Dissolution Discussion Group

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