Medical Device Quality Control

BHARAT C. DESAI

***** ****** **, ****** *******, CA-91351 Cell: 714-***-**** Email-

ab9gpg@r.postjobfree.com

OBJECTIVE

A growth oriented position as Analytical Chemist where my education,

experience and expertise can add to the company's success

SKILLS

. HPLC ( waters, Agient ), GC ( Agilent, Perkin Elmer ), UV

Spectrophotometer, Conductivity meter, FTIR

. Absorption spectrophotometer, Turbidity meter, PH meter, Hull cell, CVS

analysis, TOC

Equipment routine maintenance, Calibration, Validation, Prepare lab

Reagent standardization,

. Planning, communication, Documentation lab notebook, Instrument Logbook

. Self motivated, Independent, Hard working, Flexible, Team player

. Statistical evaluation of current data to control process & setup

process specification

. Troubleshoot software/ hardware installation, Instruments and Analytical

Methods

. Data communication and Networking, Win X, Microsoft words, Excel, Lotus

Notes, Microsoft Outlook

. LIMS, EDMS, Track wise, Agilent Chemstation, Chemstore, Truechem, Turbo

chrome, Empower, Millennium

EXPERIENCE

Norac Pharma

Quality control Chemist Irvindale, CA

Sept 2012 to Jun 2013

. HPLC,Agilent,Waters, Method Validation for MgGlycinate, ETO, Method

verification for USP, cGMP facility

. Analytical test for API production In process, Finish products

release, Stability study, Method transfer

. Analysis by GC Agilent FID for residual solvent, KF, Volumetric

titration, ID test by IR, Mol.wt determination

Gram Laboratories Irvine, CA

April 2010 to May 2012

Chemist:

. HPLC, Waters,Empower, Method development,Troubleshoot, Method

Validation, Method Transfer, Verification

. Analytical test for API, Finish products, Stability study, Product

formulation development,USP/EP Monograph

. Perform Validation study for Flumazenil,Cidofovir, Mitoxantrone,

Medroxy progesterone, Thiamine HCL

. Perform analysis of formulation study & stability study for protein by

Ion Exchange & size exclusion by HPLC

NAMSA Irvine, CA

Oct 2006 to Nov 2009

Chemistry Technologist (((

. Analyzed for Residual Ethylene oxide by GC Headspace and water

Extraction on sterilized medical device.

. Performed particulate analysis as per USP <788>, <789> for Medical

device, Pharmaceuticals, Injectables

. Water testing for TOC & Conductivity per USP, HPLC ( Empower/

millennium) method develop, Validation

. Performed analytical testing on Medical device for release and aging

lifecycle

. Conducted Dye penetration, Instron seal peel, Burst / Creep and Vacuum

leak tests for packaging integrity

Watson Pharmaceuticals Corona, CA

Oct 2005 to June 2006

Scientist - ( (Analytical R&D)

. Performed analysis on API, Excepients, in-process and finished

products using USP/NF, EP, BP and in-house procedures using

Instrumental and wet chemical methods, Residual solvents

. Conducted in-vitro determination of drug release on Immediate release,

Modified release and extended release products using dissolution

apparatus I and II

. Performed assay and chromatographic purity, Impurities determination

by HPLC ( Waters, Empower ) for the release and stability of

experimental and clinical batches

. Recorded & maintained analytical data, log books, lab notebook to

ensure full compliance with SOP, cGMP, cGLP, FDA regulations and

company policies.

. Reviewed and compared analytical results for Formulation development

batches and communicated findings and concerns to formulation

development group

Truesdail Laboratories Tustin, CA

May 2004 to September 2005

Chemist

. Analyzed blood serum & urine of Horse & Dog for drugs in racing chemistry

by organic Extraction.

. Analyzed drugs by liquid/liquid, solid phase extraction, TLC, HPLC, GC/MS

for Identification of drug.

. Sample prep & Performed drug detection analysis by immune assay, Elisa

using Neogen kits

EDUCATION

. Education Degree Evaluate as Bachelor's by AACRAO in 2009 USA

. Master of science ( Dyes & Intermediates, Organic Chemistry )Gujarat

State University, AHMEDABAD, INDIA

REFERENCES: Furnished upon request

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