Quality Control Assurance
Resume:
VARSHA JAMBUDI
M.S
SUNNYVALE, CA 94087
Home : 408-***-****
Cell : 408-***-**** E mail: *************@*****.***
OBJECTIVE
Seeking a challenging career at Biotech/Pharmaceutical field where I can apply my experience, skills and
knowledge.,
SKILLS
• Quality Control
• Pharmaceuticals / Drug Research
• Testing of HCV, HBV, HIV, MTB virus positive and negative controls by COBAS Taq Man
amplifier, Thermocyclers (PCR) and ELISA Micro plate Reader and washer..
• western blot, PCR,QPCR,RT-PCR. Cloning, primer design, and methods for DNA sequencing.
• Analysis of proteins and nucleic acid extraction by using High pure viral Nucleic acid kit.
• Standard methods including DNA isolation,, Gel electrophoresis, SDS-PAGE analysis,
• Mammalian cell culture.Hybridoma.
• HPLC EZ chrom Software of scientific software Agilent technology. Colorimetric assays,, ELISA
and immunoassay development.
• Preparation of Buffers, Reagents and Antibody conjugates..
• Quality assurance, Data entry in excel and access data base Sorting of data performance data
review, problem solving. Management and organizational skills
• Quality control and maintaince of cell dyne hematology auto analyzer.
• Standardization, calibration, verification, and control of equipment.
• Experience with GLP/GMP ICH ISO.LIMS. Hard working, persistent, team and detail oriented
PROFESSIONAL EXPERIENCE
CHEMIST: MOLECULAR DEVICE CORPORATION SUNNYVALE CA
(NOV 06- MAY08)
• Working at reagent production and .Q.C. department with laser capture microdissection.group.
• Preparation for R.N.A. Amplification High sensitive kit,, RNA Amplification Fast kit
Pico Pure RNA and DNA extraction kit and Paradise reagent kit.
• Preparation of Master built buffers need to dispense in different kits.
• Preparing different reagents used in laboratory
• performing TM3 mammalian cell culture, collection of cell lysis, preparation of Control TM3
RNA, Freezing of the TM3 cells in cryovials. Gel electrophoresis with UV Tran illuminator
imaging system.
• Preparation of human universal RNA to specific conc. for formalin fix universal RNA .
• Measuring quality of RNA, using Agilent RNA 6000 Nano Kit, RNA 6000 Nano Lab chips and
Agilent 2100 Bioanalyser. quantity of RNA by Nano dropUV-VIS Spectrophotometer.
• Quality control testing of ff uRNA, R.N.A.amplification- H.S kit. and Reverse transcript paradise kit by
using PCR and Roche light cycler (Real time PCR) and Agilent 2100 Bioanalyser.and Speed vac.
• Quality control testing of nucleic acid purification columns.
RESEARCH ASSOCIATE, ABBOTT DIAGNOSTICS, SANTA CLARA, CA
(MAR06-SEPT06)
• Working in new product development verification &.validation department..
• Performing Quality control for Cell dyn Ruby Hematology auto analyzer based. on principle of
flow cytometry.
• Conducting daily, weekly and monthly maintenance procedures for Cell Dyne Ruby.
• Performing continuous cycling of blood samples for evaluation of cell dyn Ruby Hematology
Auto Analyzer and notify if any fault occurs and if possible rectify them.
• Analysis of Blood sample for diff. hematology parameter.
• Preparation of samples for various hematological analysis using different reagents..
• Data entry in M.S. excel for Reliability run cycle worksheets maintenance.
• Maintaining the Data Log and Event log records.
PRODUCTION CHEMIST: MANUFACTURING DEPT, BAYER INC,SUNNYVALE CA
- (DEC05)
• Preparing Buffers, Reagents,.,HPLC analysis for conjugates.
• Taking absorbance on UV VIS Spectrophotometer.
• Calibration of PH meter, Micropipettes. Preparing Units of HbA1C(Monitor of gycosylated HB)
• Determination of % of M.P. by different methods.
LAB ANALYST: PRECLINICAL DEPT, INTERMUNE INC, BRISBANE CA
(APR 05-NOV 05)
• Working on Antibody testing Reconciliation project of HCV patient.
• Performing Q.A.of large (9000lines) Microsoft Excel Worksheet integrated from HCV patient
blood samples.HPLC analysis
• Data entry in excel and access data base Sorting of data. Importing data from excel to access:
including creating a database of information about samples.
• Freezing of HCV blood samples and maintain temp of freezers and samples at -80C at all times.
• Handling with Biohazards materials.
• Chemical Hygiene and Biosafety and exposure Control training
• Creating an organized storage mechanism for 4500 samples
• ELISA for antibody detection..
QUALITY CONTROL CHEMIST GENEMED BIOTECHNOLOGIES INC.
SOUTH SAN FRANCISCO (JAN 04 –MAR05)
• Performing quality control testing for HCV, HBV, HIV High and low Controls with COBAS TAQ
MAN Amplifier(RT-PCR) by using High pure viral Nucleic acid kit..
• Helping in testing for MTB High and law control by using Thermocyclers (PCR) ELISA Micro plate
Reader and washer...
• RNA,DNA extraction by high pure viral Nucleic acid kit.
• QUALITY SYSTEM OVERVIEW: looking for application of GMP/CLP and QSR. Validation
Maintenance and record of test Equipments. Receiving in process & Finished device Acceptance.
Keeping record for Environmental control.
• Maintain quality planning for methods used in, control used in, the design, manufacture,
packaging, labeling,storage,installation and serving of all finished products. Documents approval
and Distribution.. Keeping all records of quality control lab. e g DHR,DMR, Batch Manufacturing
Record (BMR), Product identification number (PIN), lot number,.
• Maintained accurate GMP, SOP, SPE, MSDS, MADS guidelines
RESEARCH ASSOCIATE, HI-TECH BIO-TECHNOLOGY LABORATORY,
INDIA (1996-2003)
• Maintaining the High –Tech Laboratory for DNA Analysis including DNA Sequencing, DNA
amplification, DNA extraction,RT- PCR and PCR primer design, Western Blot,,,
• Determination of HBsAg and HIV by ELISA ..Mammalian cell culture
• Conducted periodical audits of biological inventory. Responsible for maintenance of equipments
for laboratories of 20 scientists and technical staff to ensure quality control.
• Lab equipments included, electrophorator, PCR amplifier, UV-VS spectrophotometer.
Automated bio analyzer,
• Developed and designed project focused on Protein Purification using High Performance Liquid
Chromatography Analysis of micronutrients by HPLC.
• Used MS Word and Excel to write SOPs, maintain calibration records, and adhering to ISO
guidelines
• Trouble shooting existing procedures to improve reproducibility and accuracy of results and
exploring new technique
EDUCATIONAL QUALIFICATIONS
M.S.: BIO CHEMISTRY Gujarat University INDIA GPA:3.25
B.S.: SCIENCE Gujarat University India
Course completed
Liquid chromatography & Mass spectroscopy in drug Discovery (LC/MS): U.C.Santa
Cruz Extension. (2007)
• Biotechnology courses at FOOT HILL DEANZA COLLEGE, CA
(2007-2008)
• H.P.L.C.ANALYSIS
• D.N.A. SEQUENCES & CLONING GPA:3.2
• P.C.R RT- PCR AMPLIFICATION
• SDS PAGE ANALYSIS
• IMMUNO-CHEMISTRY: ELISA, WESTERN BLOT.
• MAMMALIAN CELL CULTURE
• MONOCLONAL ANTIBODY & HYBRIDOMA
.
COMPUTER SKILLS:
Microsoft Word, Excel, Access, Power Point, Adobe Photoshop,. Internet savvy,
VISA-STATUS--- PERMANENT RESIDENT
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