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Quality Analyst

Location:
Clifton, NJ
Posted:
February 25, 2020

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Resume:

Bhaktesh D. Desai

** ****** ******

Clifton, NJ *7012

Phone: 973-***-****

Cell :862-***-****

Email: adbzmd@r.postjobfree.com

OBJECTIVE: A position that will challenge my education, experience and acquired skills, as well as offer career advancement.

RELATED SKILLS: Instrumentation skills include Gas Chromatography, HPLC, UPLC, and UV-spectroscopy

Ion Chromatography, dissolution, Karl-Fischer titration, aerosol particle size determination, Thermal Analysis.

Knowledge of cGMPs (Current Good Manufacturing Practice) and

GLPs (Good Laboratory Practice).

Computer skills – LIMS, SAP, Excel, Word and HPLC data acquisition using Empower-3,

HP Chemstation, Total Chrom.

WORK

EXPERIENCE:

April 2010 SCIENTIST

To Cambrex/ HALO Pharma, 30 North Jefferson Road, Whippany, NJ.

January 2020 Method development and method validation for the determination of assay, impurity of API, drug substance and finished product and manufacture cleaning by HPLC and UPLC.

Conducted troubleshooting, reviewed prior-approved documents such as protocol, method development and validation reports

Documentation of SOP, method qualification/validation protocol and report.

June 2003 ASSOCIATE SCIENTIST /CHEMIST-II

To PLIVA, Inc, /Barr Laboratories, East Hanover, NJ

July 2009 Perform equivalency study between USP method and In-house Stability methods.

Prepare Protocol, Equivalency studies Report and Method Transfer Report.

Perform routine Assay and related substance, Content Uniformity and Dissolution analysis.

Perform in –depth reviews of analytical / technical report and notebooks.

Calibrated HPLC and other laboratory equipment to assure accuracy and precision

Documented all work in compliance with cGMP.

April 2000 ANALYTICAL CHEMIST -II

To CLARIANT CORPORATION, BRANCHBURG, NJ

May 2003 Performed HPLC analysis, IC analysis, GC analysis and wet analysis.

Developed new methods and Improved old methods

Updated the statistical process control chart to review process consistency

Documented all work in compliance with ISO 9000

Maintained the laboratory according to OSHA guidelines

March 1998 SCIENTIST

To AEROPHARM TECHNOLOGY INC., EDISON, NJ

March 2000 Developed method following cGMP and USP guidelines.

Performed particle size distribution using various devices, moisture content, assay, total can pressure and physical observations for Metered Dose Inhalation (MDIs).

Conducted release testing of valves and cans for MDIs.

Calibrated HPLC and other laboratory equipment to assure accuracy and precision

in accordance with cGMP. Documented all work in compliance with cGMP.

September 1997 QUALITY CONTROL CHEMIST

to CCP INC. WEST PATERSON, NJ

January 1998 Analyzed incoming raw material and bulk finished hair products.

Checked weight, labeling and packaging at packaging site

Responsible for release, holds or reject of hair product

September 1995 LABORATORY ANALYST

to MARIJON DYEING & FINISHING CO., E. RUTHERFORD, NJ

December 1998 Prepared dye solution from standard dyes chemicals.

Used computerized centrifugal machine to dye fabric samples

Checked color fastness and staining properties of dyed fabric samples.

Assured quality of standard reagents and indictors through periodic testing.

Compared results with specification manual.

Approved or rejected samples and recommend adjustments based on written guidelines

January 1992 QUALITY CONTROL CHEMIST

to SHAH INDUSTRIES, INDIA

December 1993 Performed chemical and physical testing of raw material, in-process

and finished steel products.

Communicated with production personnel to incorporate quality process into manufacturing.

Maintained company’s record retention program and customer specifications.

March 1988 LABORATORY ANALYST

to NATIONAL INSTITUTE OF OCCUPATIONAL OF HEALTH, INDIA

January 1992 Collected, extracted and analyzed air, water, soil, food and blood samples

for pesticide residues by using pesticide analytical manual provided by EPA.

Compiled test results and prepared final testing report for the Government of India

EDUCATION: Master of Science, Organic Chemistry, Gujarat University, India (1991)

Bachelor of Science, Chemistry, Gujarat University, India (1984)

Earned 2.5 credits in Instrumental Methods of Analysis at Steven’s Institute

of Technology, Hoboken, NJ (1994)

REFERENCE: Available upon request



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