Testing Quality Control

Renuka Suhagiya

Chelmsford, MA *****

***********@*****.***

617-***-**** (C)

[pic]SUMMARY of QUALIFICATIONS

Experienced microbiologist, MS in Microbiology and MS in Cell & Molecular

Biology, with extensive exposure in routine microbial testing and

microbiology method validation under cGMP, ISO and FDA regulations

Specific competencies in:

. cGMP, GLP, ISO, USP, EU, FDA

. Report for NC, OOS, ECN

. Water Bioburden and Product sterility testing

. Endotoxin (LAL) testing and Media fill

. Environmental monitoring sampling (EM)

. Microbial growth suitability testing <61> < 62>

. Preservative efficacy testing <51>

. TOC, Conductivity, Media preparation

. Utilize, maintain, microbiology instruments

. Instrument calibration, Flatness Scanning

. SOP and documentation

. pH, Scale, Spectrophotometer, BSC hood

. Antimicrobial properties neutralization testing

. Microbial Identification, Growth Promotion

PROFESSIONAL EXPERIENCE

Rapid Micro Biosystem, Bedford, MA (Research Associate in Micro)

Mar2013 - April 2014

. Writing and execute the protocol, evaluate and analyze results

statistically

. Execute Method development, Method validation and Method verification

to test prototype equipment

. Set up a series of microbiology assays to test Growth promotion, EM

(surface & Air), Disinfectant neutralization study, physical-

mechanical study of microorganisms

. flatness study of media cassettes, Image analysis for bacterial growth

in plate inspector

. Media improvement to maintain condensation and good media quality with

extra new material of cassettes

. Filtration testing for membrane and media generated in RMB,

Microorganism freezer stock preparation

. Water TTR, Linearity test, Growth promotion Equivalence test, Accuracy

and Precision test

Genzyme Corporation, Framingham, MA (Quality Control Analyst II)

Jan2012 - April 2012

. Endotoxin (LAL)- Gel clot and Turbidometric, Bioburden testing, TOC

and conductivity of WFI, RODI, USP purified water, clean steam

systems, raw material, in process and finished products as well as

rinse

. Sample collection for rinse and daily water sample from different

sites. Receiving samples from different departments and login samples

for Microbial Testing

. Enter results in iLIMS, Documentation and review the results of

others

Anika Therapeutics, Woburn, MA (Method Validation Analyst in QC Micro)

Oct 2010 - May 2011

. Expertise in Validation protocol and SOP for Microbiological testing

as per USP and EU requirement

. Review and update SOPs (Quality Standard Procedures) and Validation

protocols Testing of samples under GLP, Sampling under cGMP,

Documentation under GDP

. Method validation for purified water, raw material, in process and

finished products using microbial growth suitability testing <61> <

62>, and antimicrobial properties neutralization testing <1227>, and

troubleshooting

. Sterility testing, endotoxin (LAL), bioburden testing and TOC and

conductivity of WFI, RODI, USP purified water, clean steam systems,

raw material, in process and finished products as well as rinse

. Validation for sample retention time

. Cleaning validation testing for bioburden, Product sterility testing,

Media fill using USP test methods

. Media preparation and growth promotion testing for selective and

differential media, Biological indicator testing

. Environmental monitoring sampling- viable air, rodac contact plates,

non viable particle counts in controlled environment - ISO Class 5, 7

and 8

. Report Out of Specification (OOS) results and Environmental Control

Notification (ECN), Non-conformance, Root Cause Analysis, Risk

Assessment & investigation

. Certify manufacturing people for sterile gowning procedure,

Calibration the instruments as per needed

. Review contract lab results and update in the system, laboratory

maintenance and inventory

Amneal Pharmaceuticals Inc. Yaphank, NY (Assistant Scientist in QC Micro)

May 2009 - Oct 2010

. Microbial growth suitability testing <61> < 62>, preservative

efficacy testing <51>, and antimicrobial properties neutralization

testing <1227> under GLP and Documentation under GDP, Biological

Indicator Testing

. Purified water sampling and testing, environmental monitoring

sampling under cGMP

. Bacterial identification, fungal identification, Utilize, maintain,

and troubleshoot microbiology instruments

. Media Preparation, Growth promotion and Maintenance & enumeration of

microorganisms

. Cleaning validation testing and method development for sample

retention time, IQ,PQ & OQ for instruments

. Receiving and login samples for Microbial Testing, laboratory

instruments maintenance

Long Island University, Brooklyn, NY

Sep 2008 - Dec 2009

Teaching Assistant

. Set up laboratory practical; provide guidance and feedback to under-

graduate students in subjects related to Molecular Biology, General

Biology, Human Anatomy, Microbiology, and Bio Chemistry

. Provide technical assistance and lab reports to professors as

required

Polytechnic University, Brooklyn, NY

Feb 2008 - Aug 2008

Research Assistant

. Preparation of polymer samples and run it through Fourier transform

infrared (FTIR) spectrometer, process data

RELAVENT COURSEWORK

. Microbiology, Molecular and Cell Biology, Biochemistry, Cancer

Biology, Infection and Host Responses, Structure and Management of

Clinical Trials, Industrial Pharmacy, Biotechnology, Virology and

Mycology, Bioprocess and Fermentation, Biostatistics

LABORATORY SKILLS

. Microbiology: Aseptic techniques & sterilization, Microscopy, Maintain

aerobic, anaerobic, clinical and environmental bacterial isolates,

Single cell isolation, Microbial and fungal characterization and

identification using staining and biochemical tests, MIC,

Immobilization of enzyme, Bioleaching, Fermentation (solid, submerged)

for Amylase, EPS, lipase, organic acids, Hematological and serological

analysis of blood, LAL test, UV-visible spectroscopy, Atomic

absorption spectroscopy, TLC, Column chromatography, FTIR

. Molecular and Cell Biology/Biochemistry: Gene cloning, DNA, RNA &

protein extraction and purification, PCR, RT-PCR, DNA sequencing,

southern and western Blot, ELISA, SDS-PAGE Gel electrophoresis,

Transformation, Replica plate technique, Gel filtration, Enzyme

kinetics, Amino acid titration

EDUCATION

. MS in Molecular and Cell Biology, Long Island University, Brooklyn, NY

GPA: 3.95 (Dec 2009)

. Master of Philosophy in Microbiology, Gujarat University, India

GPA: 4.00 (Dec 2007)

. MS in Industrial & Environmental Microbiology, Gujarat University,

India GPA: 4.00 (May 2006)

. BS in Microbiology, Gujarat University, India

GPA: 3.72 (Apr 2004)

PROJECT/ SYMPOSIA

Masters of Philosophy Research Project: "Bio-extraction of metals from

industrial and mining waste"

. To standardize the chemical extraction of nickel from industrial

waste, isolate the nickel resistance microbes from garden soil and

compost by the use of replica plate technique and studied Bio-

extraction by Thiobacillus ferrooxidans

. Indirect bioleaching of copper with biologically generated ferric and

studied direct bioleaching of copper by Thiobacillus species isolated

from mining site

Masters of Science Thesis Project: "Isolation of pigment producing

bacteria and influence of various parameters on pigment of Serratia

marcescens"

Poster Presentation: "Metal removal from industrial and mining waste" at

Association of Microbiologists of India (AMI), 48th annual conference

held at Tamil Nadu, India (Dec 2007)

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