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Quality Control Testing

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Location:
PARLIN, New Jersey, 08859, United States
Salary:
60 to 80 K
Posted:
September 25, 2012
Email:
pdp01s@r.postjobfree.com
Contact Info:
*******@*****.***


ASHOK VASANT, Microbiologist
• LinkedIn: www.linkedin.com/in/ashokvasant • Email: pdp01s@r.postjobfree.com
**** ******* *****, ******, ** 08859 • (C) 732-***-**** • (H) 732-***-****

SUMMARY
Accomplished Microbiologist with experience in a variety of fields including Pharmaceutical Research and Development, Quality Control Manufacturing, Clinical Laboratory Analysis and Medical Technology along with excellent skill in computer and instrumentation. Recognized as an adaptable team member known for project flexibility and delivery of results. Enthusiastic about quick learning of new technology to meet business needs.
Skill Demonstrated Include:
• Antimicrobial Drug Discovery and Development support for Phase III-IV compounds –Doribax, Ceftobiprole and Levofloxacin. Perform in vitro Antimicrobial Susceptibility testing by MIC, Disk and ETest methods. Microbial Identification by Vitek2, API and Rapid methods. Maintenance of culture collection and database. Presentation of research data and journal articles at group meetings.
• Raw Material, Bulk and Finished Product Release with reduced cycle time.
• Manage Stability Program for Products.
• Validation of Autoclave, Incubators. Test Method Validation. Design CLEAN Room Monitoring specification for sterile manufacture facility.
• IQ, OQ and PQ for new automated equipment for more accuracy and reduce cycle time.
TECHNICAL PROFICIENCIES
Research Quality Control • Preservative Efficacy
• CLSI Methodology • Bioassay-Antibiotic • Disinfectant Study
• Susceptibility • Preparatory Testing • Environmental Monitoring
• Trek Sensititre • Microbial Limit Test/Bioburden • Validation/Calibration
• Vitek2, API • ATP Bioluminescence-Celsis • Packaging/Cleaning Validation
• Liquid Handling BioMek Fx • Biological Indicator Testing • LIMS/NOR/NCS
Medical Technology • Sterility Testing • cGMP/GLP/Data Trending
• Hematology-Colter • Aseptic filling/CAMA • FDA/CBER
• Chemistry- Paramax • LAL Endotoxin Testing • USP Compendia /CFR
• Serology/ Culture Sensitivity • ATCC Culture Maintenance • Writing SOPs
• Radio Immuno Assay • Water / Growth promotion • Microsoft Office 2007
PROFESSIONAL EXPERIENCE
JOHNSON AND JOHNSON Family of Companies. Raritan, NJ 1994 – 2012
Ortho Clinical Diagnostic, J&J Medical Device and Diagnostic NJ March 2011-Present
Scientist – Microbiologist.
Work in QA-QC Microbiology product release group. Testing and Releasing various diagnostic blood products Bulk, In Process, Finish product and Water-LAL using MD& D guideline. Review Paper work and SOPS. Data Trending.
• Enhanced Ergonomic Process for test method using Milli snap.
• Enhanced safety for waste product disposal.
J&J Pharmaceutical Research and Development, Global Pharmaceutical, Infectious Disease NJ
Research Associate (Analyst II) 2006 – July 2010

ASHOK VASANT Page 2
Antimicrobial Susceptibility Testing (AST) - AST by broth microdilution MIC and Disk testing following CLSI (Clinical Laboratory Standard Institute guidelines) methodology and ETest.
Prepared MIC assay plates by manually pipetting, by automation- BioMek FX robot and used custom panels. MIC determining, read manually and by use of Trek Sensititre Vizion System.
Maintain Culture Collection and Database. Generated and analyzed data for initial meetings, creating spread sheets, graphs and charts. Trending Data.
• Support Phase III-IV compound-Doribax (Doripenem) working on Phase IV studies and
ceftobiprole under regulatory review.
• Recognized in Team for Maintaining Clinical Isolates and Database.
(J&J) Global Pharmaceutical Sourcing Group, PSGA, Ortho McNeil, Ortho Biotech, NJ
Microbiologist 1994 - 2006
Performed microbial testing on drug Substance; finished topical, oral, and sterile products, and release products according to specification in timely manner. Investigate root cause. Qualified Disinfectant. Qualified Biological Indicators. Performed USP LAL endotoxin and sterility (Bacteriostasis and Fungistasis) testing for Parenterals and Biological Products. Supported Stability protocol and testing. Managed packaging environmental program by testing packaging facility, fill line equipments and product container and cleaning validation. Participated in cost saving and reduce cycle time project for product testing.
• Validated automated Steriscreen (Celsis – ATP Bioluminescence Technology), which increased accuracy and reduced product testing time to four days.
• Changed dilution method for Erythromycin Antibiotic Assay. Resulted in cost savings for expensive USP Standard.
• Performed Requalification of Media by Growth Promotion Testing extending shelf life of media a cost savings for company.
• Eliminated extra testing for water activity of suppositories, showing data trending, results and suppositories were not a part of USP requirement for water determination.
• Helped revise SOPs and Test Method Procedures and Review data. Wrote Protocol.
• Participated in internal audit and involve with preapproval product team for FDA audit.
• Presented article on Antimicrobial Preservative Efficacy testing for improve test method and cost saving approach.
• Helped develop LIMS system giving end user feedback and using in-depth knowledge of computer science.
• Performed Scientific Review for Laboratory Information Management system.
• Received three awards for Team Work.
Advanced Remedies/Akorn (Ophthalmic Sterile mfr.) Somerset, NJ 1992 – 1994
Microbiologist
Multi Tasking approach for small sterile manufacture facilities with clean room (Class-100) technology. Wrote SOPs. Performed product testing. Monitored static and dynamically viable (microbial) and non viable particle for class 100 clean room and established microbial specification.(CAMA) Determined viable particles by RODAC plates, RCS and settling plates and non-viable particles by Metone Laser particle counter. Validated aseptic filling by media fill. Managed yearly requalification for autoclave, incubator, laminar flow hood and HAPA filter (DOP fill). Validated Autoclave and Incubators, heat distribution study and heat penetration study for different load configuration of autoclave by K- Machine using T thermocouple. Performed bioburden studies for empty tin tubes and bottles to set the dose (mrad/hr) for gamma radiation.
• Received FDA approval for ophthalmic solution for glaucoma and ointment, expanding company size.
• Recognized as a key person contact for Microbiology Laboratory and operational facilities because of clean room’s microbiological need.
• Trained Laboratory Personnel in Microbiological Test Procedure.
Clay Park Lab, Pharma mfr. New York 1989 -1992
Microbiologist
USP/CFR Antibiotic (Bioassay) Assays: Determination of potency of various antibiotics including Erythromycin, Gentamycin, Polymyxin, Nystatin and Bacitracin using the agar diffusion method (also experience using Thermomax instrument). Water analysis.
Chemistry:
Physical testing of Raw Material, Chemical testing of Water, Moisture Determination, TLC for Identification. Calibration of lab instruments which includes UV / spectrophotometer.
• Managed two persons for stability product testing program.
• Elmer Community Hospital, Clinical Lab., Elmer, NJ 1988-1989 Laboratory Technologist
• Experienced in various departments including Hematology, Serology, Chemistry and Microbiology. Instrumentation includes Coulter T series (hematology), ACA, TDX, Astra 8 and Paramax instruments (chemistry) and Rast assay for allergy test (RIA method).
EDUCATION & PROFESSIONAL TRAINING
• BS MICROBIOLOGY: Minor: Chemistry, Math. Gujarat University.
• Medical Laboratory Technology. K.M. School of Post-Graduate Medicine & Research institute, India
• Radiography E.C.G. Technologist. Gujarat Technical Examination Board.
• Computer: – Middlesex County College, New Jersey, – Towards Associate Degree in computer science completed core computer courses.
• Computer Training: Windows, XP, Word office 2007 (PowerPoint, Excel), & Deviation Observation Response System (OOS), LIMS: Laboratory Information Management System.
• APHL 2009 CLSI standards for Antimicrobial Susceptibility Testing Updates training. Jan -2009.
• Attend BioMek Backman Coulter automated (robot) System training. Jan- 2009.
• Sensititre Swin training program (Trek Diagnostic system) for new vision plate reader. May- 2009.
• Rapid Microbiology for Regulated Industries (ATP Bioluminescence) Validation of Celsis. (By PDA) 1998.
• LAL Methodology and Application: Associates of Cape Cod, MA. 1997.
• CQA: Attended classes for Quality Audit by American Society of Quality. Nov 1997.
U.S. Status: Citizen.