Quality Control Testing

Vishakha. N. Patel

*** *. ****** ***, ********, MD-21001

Email :- acd0s9@r.postjobfree.com

Phone :- 239-***-****

Objective : Seeking a quality environment where my skills and knowledge

as a QC Microbiologist can be shared and enriched to work in a

progressive work culture with all freedom to be creative and innovative.

Summary :-

. Self- motivated professional with 5 years of varied experience in

Microbiology Quality Control and the sciences including related

technologies.

. Professional with vast experience in cGMP, cGLP, FDA Regulations, OSHA

Regulations and NH Guidelines.

. Good understanding of Environmental Monitoring and microbiological

testing.

. Experienced with SoftMax Pro, Vitek 2 compact system, Biolog, LIMS,

SAP, eDOCS and Track Wise software, WinKQCL software.

. Experienced with instruments such as CLIMET, AIR IDEAL, EMTEK.

. Expertise in implementing environmental monitoring programs, ensuring

compliance with cleanroom regulations, establishing safety management

systems, and completing cleanroom validation.

. Highly optimistic, team oriented individual with a hands-on / can- do

attitude, ability to work efficiently and independently.

. Experience in lab monitoring of all instruments, standardization of PH

Meter and analytical balance.

. Performed routine static and dynamic monitoring for personnel, viable

surface, active and passive viable air, temperature, non-viable air

particulates and differential pressure, humidity and WFI systems.

. Microbiological testing of raw materials, finished product and

components using aseptic technique.

. Expertise in antimicrobial testing requires a solid understanding of

not only the tests required but the microbiology of the organisms

tested and regulatory compliance needed.

. Familiar with all applicable SOPs, policies and regulations testing to

a cGMP & cGLP environment.

. Water analysis, environment monitoring, Raw material and product

analysis( test performed - sterility, LAL, and Assay tests).

Skills :-

. Microscopy, microbial cultures and samples preparation.

. Growth, Isolation and identification of microorganisms, Water Testing

( DM water, DW water, Potable water), Microbial limit testing &

pathogen testing, Bacterial Endotoxin test.

. Isolation and purification of the microorganisms, Antibiotic

sensivity.

. Identifications of microorganisms by biochemical tests,

. Sterility testing, Bacterial endotoxin testing.

. Skill and knowledge in immunological test methods such as ELISA and

western Blot.

. Excellent interpersonal communications skills, strong leadership and

problem solving skills, deadline sensitive and able to work well in a

group setting or independently.

. Bacterial staining( as Gram staining), Microbial assay of antibiotics

by diffusion method.

. Laboratory testing and analysis, HPLC analysis, UV Spectrophotometer

analysis.

Professional Experience :-

Emergent Bio Solutions, Baltimore, MD Aug

2012- Present

Quality Control Microbiologist

. Performs daily scheduling for QC analytical testing

. Implemented microbiological assay improvements through SOP revision in

eDOCS system and internal collaboration.

. QC SOP creation and revision for continuous process improvement.

. Responsible for training of QC technicians.

. Performs water sampling of WFI, USP and pure steam.

. Performs testing such as Microbial Limit Testing (MLT),Total Organic

Carbon (TOC) and conductivity, Total Microbial Count for water

testing.

. Performs LAL testing by WinKQCL software.

. Performs Growth promotion testing.

. Performs Aseptic sample processing and bio burden analysis, Bacterial

Endotoxins (USP water testing ).

. Write and update SOP's to comply with CFR and USP requirements.

. Led microbiological testing on purified water samples.

. Led in sampling and testing of cleaning validation samples.

. Collected, processed and tested samples of raw materials, finished

products in process, components, water, validation, cleaning

validation, R&D samples and AME according to company SOPs.

. Review, revise and update- company documents, SOPs test results and

documentation in LIMS, Complied with cGMP, GLPSs and FDA regulations.

. Performs Environmental Monitoring (EM) : total non-viable particulate

counts by CLIMET instrument and total viable counts by AIR-IDEAL

instrument, viable surface monitoring, water systems sampling, clean

compressed air and gases sampling by EMTEK instrument.

. Performs identification of microorganisms by Gram Staining and Vitek 2

system, LAL testing, Microbial limit test.

. Lead investigations and deviations( track wise) for out of level and

out of specification results and other compliance issues then

create/driver proper corrective and preventive actions (CAPA) to

resolve it.

. QC Microbiology point of contact as a subject matter expert for

microbiology/validation qualifications studies, investigations,

deviations, batch record entries, PMS and trending reports.

. Participate in validation projects like PQ of Gases, Compressed Air,

process validation and cleaning validation.

. Performs microbiological and sterility testing for release of raw

materials and finished products according to approved procedures.

. Performs environmental testing and train other personnel on

procedures, Samples receipt and documentation.

. Work lists generation and data entry and reviewed documents into

Laboratory Information Systems (LIMS).

. Create reservations for materials and Purchase Requisition (PR) via

SAP access.

Astral Pharmaceutical Ind,

May 2008 - July 2011

Quality Control Microbiologist

. Experience in lab monitoring of all instruments, standardization of PH

Meter and analytical balance

. Performed Media preparation and maintain record of all logbooks

regarding media preparation.

. Performed Preservative Efficacy Testing on regular basis.

. Performed water testing including bio-burden, LAL testing, microbial

limit testing, TOC and conductivity.

. Experience in equipment and line clearance for manufacturing and

packaging operations.

. Performed trending of EM, Water and Compressed Air Data.

. Responsible for daily support and oversight of the Environmental

Monitoring (EM) program in clean room fill suite.( sampling, testing,

critical decision-making and staff training).

. Responsible for developing safety training, preparing policy and

procedure pertaining to environmental, health and safety (EHS)

program.

. Performed Tilter Value and Growth promotion test.

. Performed identification of microorganisms by Gram Staining and Vitek

2 system.

. Assisted in trending water and EM for quarterly and annual review.

. Performed routine static and dynamic monitoring for personnel viable

surface, active and passive viable air, temperature, non-viable air

particulates, and differential pressure, humidity and WFI systems.

M.S. University

June 08-April 09

. Project- isolation characterization and evaluation of Endophytes.

Presentations

. RIA ( Radio Immuno Assay)

. Cells of Immune System

. Animal Virus.

Education :- MS in Microbiology, SP University,June 2009, GPA : 3.4

BS in Microbiology, SP University, May

2007,GPA : 3.0.

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