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Quality Control Customer Service

Location:
8820
Posted:
June 01, 2011

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Resume:

VASANTHA GADAMSETTY

***********@*****.*** 732-***-****; 48 Rain ford Edison NJ 08820

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AREAS OF STRENGTH

. Work related Experiences: Excellent working knowledge of GMP, GLP,

protocols, FDA regulations, and OSHA requirements.

. Demonstrate a broad-ranged knowledge of failure analysis investigations

of non-conformances and CAPAs, trending and statistically analyzing data,

writing and reviewing validation protocols and reports, writing SOPS and

reviewing changes to SOPs.

. Hardworking, reliable and flexible; willing to work long hours and

additional shifts to complete a project.

. Exercise independent judgment appropriately; communicates problems

through proper Company channels.

. Complete assignments under minimal supervision; work well independently

and as a team player.

. Strive to suggest creative solutions aimed at improving productivity

levels and working conditions.

. Detail and results-oriented; enjoy learning new skills; strive to

increase productivity and efficiency levels.

. Laboratory procedures and Experience: DNA Isolation, DNA Quantification,

DNA Culturing, PCR, ELISA, DNA Sequencing, Southern Blotting, Western

Blotting, Northern Blotting, Protein Estimation, Protein Purification,

Chromatography Techniques ( HPLC, Reverse phase HPLC), phlebotomy, Primer

designing, Human cell growth (He La Cells), Flow cytometery and DNA

transfect ion, Gram staining, Media sterilization techniques, Inoculating

cultures, Aseptic Techniques, streaking and colony counting, pouring

plates and media preparation.

. Computer skills: Microsoft Windows, Microsoft Office (including Word,

Excel, Power-Point), MS-DOS, Visual Basic, C, ASP, XML, HTML, LIMS,

MINITAB and Internet Explorer.

Graduate course work:

Cell and molecular biology; Applications of stem cells in medicine; Cancer

and Hematopoetic stem cell studies; Introduction to genomics, proteomics

and bioinformatics; Molecular Virology; Molecular mechanisms of human

diseases. Biochemistry; Molecular Biology; Immunology; Cell Biology;

Genetics; Tissue Culture; Microbiology; Chemistry ; Bio-informatics ;

Genetic Engineering; Biochemical Engineering ; Fermentation technology;

EDUCATION

M.S of Biomedical sciences

University Medicine and Dentistry (UMDNJ), NJ

Master of Biotechnology

Nagarjuna University, India.

BS (Chemistry, Botany, and Zoology)

Nagarjuna University, India.

Microsoft Certified Professional - Visual Basic Programming.

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PROFESSIONAL EXPERIENCE

Related Research and Lab Experience:

Libra Technical Labs, Metuchen, NJ

04/2010 - present

Quality control Scientist

. Perform Microbial testing on specialty care products, Food corporation

and pharmaceutical water testing and conductivity, health products like

vitamins as per USP.

. Bacterial, yeast and mold culture maintenance.

. Identification of organisms using biological indicators.

. Revising and maintenance of Sop's and General Methods.

. Actively involved in investigation of failures.

. Involved in development of new methods and protocols.

. Aseptic techniques/ Sterility Testing

. Media preparation and dilutions

. Environmental Monitoring (Rodac, VITEK), air testing, water testing

. Bacterial Endotoxin Test (LAL Gel-clot method)

. Microbial Limits

. Anti-Microbial Effectiveness Tests or Preservative Efficacy Testing (PET)

. Growth Promotion Testing

. Review/Revise Standard Operating Procedures (S.O.P.'s)

. Quality Control and Quality Assurance Documentation

Graduate student, Dr.Hong Li's lab, NJMS-UMDNJ, USA

11/2009 - 03/2010

Rotation Project: Effect of Apoptotsis, which was induced by H2O2 in the

presence of over expression of SMYD1 Gene in He La cells using FCAS

analysis technique. During this study I used Microbiological techniques

like E. coli growth and maintenance, Plasmid construction, primer

designing, Human cell growth and maintenance, transfect ion.

Involved with customer service department in protein analysis using HPLC,

reverse phase chromatography, western blotting, ELISA of cancer and

experimental samples.

Graduate student, Dr.Depre's lab, NJMS-UMDNJ, USA

03/2008 - 06/2008

Rotation Project: Gene silencing and subcellular localization of rictor in

293 cells (Techniques used: western blotting; siRNA transfection;

immunostaining). And also involved in Genotyping screening using PCR,

Realtime PCR.

Assisting the Post Docs, in plasmid construction, Maintaining E.coli for

transformation, Ligation and also in Lab supplies ordering and keeping

chemicals up-to-date.

International Technidyne Corporation - Edison, NJ

February 2002 -2007

Quality Control Supervisor

July 2006 -October2007

. Thoroughly knowledgeable in the QC testing procedures and assists with

same as required ensuring timely product release.

. Works with Technical services, QA, Manufacturing, R&D, Clinical Affairs

and Marketing as required investigating and resolving non-conforming

material and performance issues and maintain up-to-date testing

procedures (Standard Operating Procedures).

. Coordinates maintenance of the documentation files of approved QC

Standard Operating Procedures in compliance with ISO09001/EN/ISO 13485

standards, testing data, performance study results and management of the

respective laboratory QC database.

. Provide the daily supervision of laboratory staff members and ensure that

the administrative functions of the lab are executed in a timely and

complete manner.

Quality Control Technologist II

January 2004 -June 2006

. Assist in maintenance of the documentation files of approved QC Standard

Operating Procedures.

. Train and supervise other laboratory technicians

. Perform batch record audits as required under standard QA procedures.

. Responsible for the release of raw materials, in-process and finished

products.

. Work with technical services, QA, manufacturing, R&D, clinical affairs,

and marketing as required to investigate and resolve customer complaints,

performance issues, and to monitor trends.

. Responsible for the execution of a broad range of bench test procedures

used in raw material qualification, testing of finished goods prior to

release, the investigation of product performance and the conduct of

routine validation studies.

. Assist in the development of a new data management system as well as

serving as LIMS administrator.

. Microbiological testing including bioburden, water monitoring.

. Responsible for routine maintenance of the QC laboratory.

Quality Control Technologist

February 2002 -Dec 2003

. Responsible for the execution of a broad range of bench test procedures

used in raw material qualification, testing of finished goods prior to

release, the investigation of product performance and the conduct of

routine validation studies.

. Trained and familiar with phlebotomy technique.

. Responsible for the release and testing of Biomedical instruments

(Coagulation Instruments).

NAGARJUNA UNIVERSITY - GUNTUR, INDIA September

1997 - March 1999

Research/Teaching Associate

Project Title:

Statement Of Aldose Reductase Gene During In-Vitro Transmission of

Promastigotes to Amastigotes of Leishmania Donovani

Project Title:

Construction of Phylogenetic Tree for a Particular Gene (Construction of

the phylogenetic tree)

Project Title:

Selective Induction Of MIP-1Alpha A Chemokine, By Peritoneal Macrophages

Of BALB/ c Mice In Response To Leishmania Donovani Infection

Project Title:

. Genetic Polymorphism Studies of Leishmania Field Isolates by Random

Amplified

. Polymorphic DNA Detection of mRNA statement of MIP-1alpha using

Northern Blotting

. Discrimination of various isolates of L. Donovani species using

Random Amplified

. Polymorphic DNA method

NATIONAL BOTANICAL RESEARCH INSTITUTE - INDIA May 1997 - August 1997

Research Associate/Intern

Project Title: Recombinant DNA

. Preparation of different types of agar media, serial dilutions

. Experiments involving cultivation of bacterial strains,

Isolation, maintenance.

. Plant transformation techniques, Co-infection techniques.



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