Highlights:• Environmental Monitoring • Sterility Analysis • Microbial Limit Test • Swab Recovery (RODAC) • Media Fill Simulation • Disinfectant Efficacy Test • Smoke Study (CRABS) • Media Fill Visual Inspection • Steris Steam Autoclave • Gowning Qualification • Raw material Method Validation • OOS, OOT, and Deviation • USP, FDA, ISO and cGMP • Water Analysis (Purified, WFI, RAW and PSGS) • Bio-burden test (In process Pre and post filtration) • Antimicrobial Effectiveness Test • LAL-Test and Depyrogenation • Non-Viable Particle Count • Container Closure Integrity Test • MODA-EM, FDC, LIMS, SAP, LMS and SCORE • SAS, PBI, Milli flex, M Air T • Master Control, Trackwise • Personnel and Self Personnel Monitoring • Coating Solutions Hold Time • Biological Indicator Evaluation • Sterility Assurance Level (SAL) and QRM

Skills:• Environmental Monitoring • Sterility Analysis •

Goal:Versatile and Innovative Microbiologist with 6+ year track record successfully mitigating risks while Leading Projects, Expertise in improving microbiology laboratory operational excellency and increasing Quality of product. Experience includes Time Management, Leadership, Integrity, flexibility and Efficiency. Leverages technical expertise in GxP Computerized software setup/Configuration to provide exceptional support and resolve critical operational issues. Demonstrated ability to collaborate with Cross functional departments and the management.

QA Microbiologist 04/2018 - current
BAYER CONSUMER HEALTH, MYERSTOWN, PA United States
Industry: PHARMACEUTICALS
QC MICROBIOLOGY
• Perform Environmental monitoring of the clean rooms (under ISO and USP specifications) by utilizing Fall Out Plate, M Air T and RODAC. • Perform in-house microbiological assays, water testing and other sampling procedures. • Perform NVPC (Non-Viable Particle Count) in Mexico clean class GMP environment. • Sample Hold Time Study Coating solutions for TAMC and TYMC. • Prepare Agar Media for environmental monitoring FOP, MAT and Surface Method. • Operate Steam Autoclave for Solid, Liquid disposals and Dry Goods on an everyday schedule. • Create, Revise and Format Microbiology Laboratory E-Forms for testing purposes. • Perform daily Calibrations for Microbiology Laboratory weighing balances. • Prepare approved disinfectants for routine and Microbiology laboratory cleaning purposes. • Perform Biannual Cleaning and Weekly Cleaning in Microbiology Laboratory.--
QA Microbiologist 03/2017 - 03/2018
KVK TECH Inc, philadelphia, pennsylvania United States
Industry: Pharmaceuticals
QA-Microbiologist proficient on GxP system MasterControl Implementation, LIMS operation ,LMS,Vitek-2, MODA-EM ,MODA-FDC for Environmental monitoring and water analysis ,Microbial Limit test ,raw material method validations.
• Collaborated with the QC System specialist to develop and implement MODA-EM and FDC for the Microbiology Laboratory. • Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department. • Manages project timelines as it pertains to QC Microbiology Technical Service support. • Flexibility to learn and adapt to changes in procedure and work environment. • Compared Syspro raw material reconciliation with manufacturing inventory cards and manually verified the remain net quantity. Reviewed ANDA batches prior submit to FDA for approval.--
Sr Associate Microbiologist 12/2013 - 11/2014
Mylan, WEST VIRGINIA, United States
Industry: Pharmaceuticals
QC MICROBIOLOGY
• Demonstrated proficiency in Aseptic Process Environmental Monitoring, Aseptic Testing, Microbial Monitoring, Gram Staining, Sub-Culturing, Bacterial Endotoxin Testing, Bio Burden Testing, TOC, Platting, Membrane Filtration and other USP testing. • Perform accurate and timely Sterility Testing per procedure and report results per cGMP/GLP/GDP Guidelines. • Perform microbiological testing for raw materials, in-process materials, intermediates and final product. • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis. • Troubleshoot instrument problems and work with the lab supervisor/manager and equipment manufacturer’s technical services to resolve the issues. • Act as a MODA EMTM system administrator for Environmental Monitoring and Water Analysis. • Conduct Internal Lab meeting for Level-1 and Level-2 for Environmental Monitoring with Production schedule. • Investigated Environmental Monitoring, USP- Purified water, Bio-Burden, Microbial Limit Test, Sterility and Media Fill Failure observations. • Reviewed all water, raw material, environmental monitoring, steam autoclave, growth promotion, media preparation, and sterility reports. • Supervised Media fill simulation visual inspection and internal audited in production aseptic areas. • Maintained all microbiologist’s media fill, gowning, personnel, water, sterility qualifications and Requalification’s. • Routed all Deviation, OOS, OOT through Trackwise computerized GxP system. • Inspected Media Fill Vials after 14 days Incubation and reconciled all the filled vials and rejected vials. • Experienced on USFDA and all customer audits.--
Executive Microbiologist 10/2010 - 12/2013
Strides Arco Lab Limited, bangalore, karnataka India
Industry: Pharmaceuticals
QC Microbiology
• Performed Environmental Monitoring in Aseptic Filling Room, Adjacent rooms and Ware House through MODA-EM and MODA-FDC. • Surface swab Recover method in aseptic area and validation. • Analyzed USP Water by Membrane Filtration methods for Total Aerobic Microbial Count (TAMC) and Test for Specified Microorganism (TFSM). • Prepared USP Water, Environmental Monitoring, LAL, Sterility monthly trends, and annual trends. • Tested Bio Burden Bulk Solution 100 ml routine sample for TAMC by membrane filtration method. • Prepared ready reckoners for all bioburden, finished, raw material, stability based on USP and FDA regulations. • Represented Vitek-2 ID system for failure investigations and for all action level Genus Level Microorganism identification. • verified Enviro Chamber temperature monitoring Printouts daily basis. • Qualified on Self Personnel Monitoring, gowning qualification, visual inspection, NVPC during Media Fill simulations in aseptic filling rooms. • Created all EM-OOS, OOT, and Deviation through Trackwise. • Completed all internal and global training through the Learning Management System (LMS). • Maintained all in-house prepared and Third-Party Qualified Media Reconciliation. • Experienced on Customer audits and regulatory audits.--

Nagarjuna university 03/2002 - 05/2005
guntur, andhrapradesh, India
Degree: Bachelor's Degree
Major:botany,zoology,chemistry,microbiology
full time bachelor degree

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