Chemist Medical

Amita Shah

Edison, NJ ***** *****.****@*******.***

732-***-**** linkedin.com/in/amita-shah-7ab70418/

SENIOR CHEMIST

Accomplished Senior Chemist with experience executing and assisting analytical testing per ICH guidelines and using USP/NF for various projects. Proficient at performing method development from scratch/validation/finished good/in process and stability samples for medical devices for Assay/CU dissolution, KF, GPC, GC using UPLC/HPLC, Empower-2 and Turbo chrome software. Areas of expertise include:

•Method development/Validation

•UPLC/HPLC/Dissolution using App 1, 2, 7, 4

•Performing Assay/CU/Degs

•Various Pharma analytical testing

•Data reviewing/QA Auditor

•GPC/GC/KF/NMR

EXPERIENCE

Cosette pharma, South plainfield, NJ

QC Chemist August2019-May2020

•Performed Raw material, Finished good tesing for Tropical and dermatology products

•Helping production by supporting in process testing

•Performed wet chemistry testing

•Performed stability testing

Medtronic-TYRX INC, South Brunswick, NJ January 2013 – March 2019

QC Chemist-III

Performed contract lab testing, reviewed data, and analyzed results. Created COA for all products and resolved FDA comments for medical devices.

•Performed NMR, MW, GC, LOD, and KF Testing for Final Polymer and Benzyl polymer.

•Performed Monomer analyses using UPLC/HPLC and standardization of in-house standards.

•Assisted all analysts in troubleshooting instruments.

•Worked weekends as required to support in process samples.

•Helped QA in receiving raw material for production and in reviewing batch records for production.

West-ward Pharmaceuticals, Eaton Town, NJ March 2011 – November 2012

Pharmaceutical Senior Chemist

Followed ICH guidelines for testing, using USP/NF for various projects. Performed method development from scratch/validation for different projects for dissolution using empower software, Apparatus 1, 2, 7 and 4, Assay/RC using HPLC/UV/Dissolution.

•Utilized various instruments including Agilent, Waters HPLC, Distek, Van kel disso apparatus, and Perkin Elmer.

•Performed Assay/Degs/Impurity/Dissolution, FTIR/UV-Vis for finished good, in process and Stability testing using HPLC, Dissolution, UV-Vis, KF moisture testing, pH test, Hardness, Friability and weight variation.

•Wrote protocol, validation reports, and stability reports for method validation and method verification for research work.

J and J, Skillman, NJ March 2009 – December 2010

Analytical Chemist

Performed Method development, Method Validations, Method Transfer, Stability testing using HPLC, Dissolution, UV-Vis, KF moisture testing, PH test, Viscosity, Assays, Impurity/Degs, TLC testing.

•Wrote Analytical methods, Specifications, and Protocols in GSS for global use.

•Maintained working knowledge for GSS, one source, Gears, Connect, Fusion LIMS, Empower 2.

•Authored Connect system and served as a facilitator for the Connect System.

•Supported a broad range of consumer products such as Skin Care, Beauty Care, Baby Care, Oral Care, Wound Care and Women's Health Care.

Amita Shah *****.****@*******.*** Page Two

ADDITIONAL RELEVANT EXPERIENCE

Shering Plough, Kenilworth/Summit, NJ (06-200*-******)

Associate Scientist

Cardinal Health, Somerset, NJ (06/2002-04/2005)

Associate Scientist

Dura-Med, Somerset, NJ (06/2000-02/2002)

QC Chemist

Glenwood, Piscataway, NJ (12/1997-05/2000)

Chemist

EDUCATION

Master of Science (M.S.) in Analytical Chemistry

Gujarat University, India

Bachelor of Science (B.S.) in Chemistry/Physics

Gujarat University, India

PC Application Specialist

Middlesex County College, NJ

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