SUMMARY:

• Over 5 years of diversified experience in the field of Quality Assurance /Software testing with exposure of both Manual and Automated Testing of stand alone, client/server and web applications.
• Highly skilled Software Engineer with seven years of significant and progressive experience in Computerized Systems Validation, Automation and Quality Assurance in the Biotechnology/Pharmaceutical and Medical Device industry, with a solid background in Laboratory Equipment, Manufacturing Equipment, Medical Device Validation, Verification and Information Technology.
• Knowledge of SDLC and its phases.
• Experience of using manual test scripts to test and validate pharmaceutical applications in the event of a data center failure/recovery.
• Very strong to Performing functional, application, regression and performance Testing and Analyzing test results, requirement documents to ensure functionality also involved in Analyzing database results.
• Experience of testing regulations in particular 21 CFR Part 11(FDA regulations for electronic signatures).
• Strong experience with FDA regulated environments under 21 CFR Part 11, 210, 211 and 820 proficiency in Quality Systems, Computer Systems Validation regulations; ISO 9001:2000, 16949, 13485.
• Proficient with System Protocols and Validation Protocols (IQ/OQ/PQ) for Software Validation, Laboratory Equipment Validation, Computerized System Validation, Bioprocess Systems, SCADA Systems, PLC, DCS Systems, Automation and LIMS.
• Proficient in analyzing Business Requirement and Functional Requirement Specification Documents and expertise in developing test Plan.
• Experience in designing, developing and executing test cases, test scripts and test strategies.
• Performed extensive Backend Testing of data validation of applications using SQL queries.
• Executed SQL statements to check if the data integrity has been maintained.
• Experience in different types of testing such as integration testing, regression testing, system testing and UAT.
• Extensive knowledge of SDLC (Software Development Life Cycle) such as Waterfall, Agile and Spiral.
• Profound understanding of insurance policies like HMO and PPO.
• Experience with HIPAA 4010/5010 versions and EDI transaction codes such as 270/271(inquire/response health care benefits), 834(Benefit enrollment), 835(Payment/remittance advice), 837(Health care claim), 276/277(Claim status).
• Knowledge of workingwith x12 format.
• Tracked and reported bugs using Quality Center.
• Wrote complex SQL queries to perform the backend testing using Toad.
• Executed SQL statements to test the integration between application and database.
• Maintained Test Matrix and Requirement Traceability Matrix.
• Proficient in performing functional and data driven testing using QTP

TECHNICAL SKILLS:

Testing Tools: QTP (Quick Test Pro)

Bug Reporting Tool: Quality Center, Bugzilla, Jira

Databases: Oracle, MS SQL Server, MS Access, DB2

Language: Java, Visual Basic, HTML, XML,C#,C++

Operating systems: Windows XP/7/Vista, UNIX, LINUX

WORK EXPERIENCE:

Confidential, Westborough, MA

QA Engineer

Responsibilities:

• As a key member of the QA team, I was responsible for creating the test plan, high level test case documentation & complete End to End testing. Was involved in the creation of both the Shell test cases and the Site specific test cases.
• Created and maintained the 21 CFR Part 11 Assessment.
• Coordinated with System Analyst to make the Server and Machines qualified through complete IQ/OQ procedures. performed full Validation life cycle, SDLC (UR, FS, DS, IQ, OQ, PQ), deviations, change control requests, Validation report and Medical Device risk assessment
• Involved in software testing with the ability to follow written procedures.
• Assists in building audit trail of DR activities, deliverables and traceability for projects.
• Review computerized systems Validation documents such as: Requirements Specification Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, and Data Migration Plan. Pre/Post Executed Test Scripts. Traceability Matrix. Release to Production Statements.
• Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes.
• Follow SOPs and industry best practices.
• Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer Validation, project Validation status, and other relevant issues.
• Assist in planning, implementing, and documenting user acceptance testing.
• Direct and review testing.
• Provide guidance on quality issues that affect the integrity of the data or the system.
• Prepare Validation summary and test summary reports.
• Facilitate the Computer system Validation Risk Assessment to identify governing regulations and Validation deliverables during the development of the computer system.
• Review Validation deliverables for projects which are contracted to third party suppliers.
• Obtain and respond to QA review.
• Participate in establishing standard quality and Validation practices.
• Independently assess compliance practices and recommend corrective actions.
• Approve validated computer system related change requests.
• Monitor regulatory and inspection trends and advice the business on suitable action.
• Performed Validation testing on the application in accordance with 21 CFR Part 11.
• Developed Traceability Matrix to track requirements during the QA Testing Phase.
• Maintained the Requirements Traceability Matrix (RTM).
• Involved in gap analysis to find the gap between functionality offered by Oracle Clinical and our business requirements.
• Implemented c GLP and c GMP during the testing of Oracle Clinical
• Was involved in the automation of business critical test cases using QTP and Quality center to perform functional testing
• Was responsible for automating all the business critical scenarios within a period of 7 weeks using QTP and QC business process testing.

Environment: Windows UNIX, Quick Test Professional, Maximo, Waters Empower, LIMS (Watson, Lab ware, Quality Center, Peregrine, Solution Tracking System, MS Project Manual Testing

Confidential, Birmingham, AL

QA Tester

Responsibilities:

• Worked with Business Analyst and QA Lead in reviewing and analyzing the business requirements Documents and functional requirements.
• Develop test cases for different HIPAA formats 4010 and 4 Enrollment, 276 claims Inquiry, 277 Status Report, 837 Electronic claims).
• Checking different formats of EOBs, checking RPAs for different types of professional and Institutional claims.
• Provided SDLC Methodology for developing HIPAA EDI applications used by hospitals to completely automate payments posting for Medicare, Medicaid and commercial payers electronic payments files.
• Extensively involved in Data Hub Back - End Testing using Oracle SQL Server; performed daily process testing using SQL scripts execution and logged test results in Quality Center
• Prepared Test Cases based on business requirements and business rules for HIPAA EDI
• Tested all HIPAA transactions for multi version support (4010 and 5010) and validating the database to file elements.
• Performed Positive and Negative Testing using QTP.
• Performed data driven testing using QTP.
• Tested C# ASP.NET applications with White Box and Black Box testing.
• XML validation for Database schema.
• Performed Security Testing on the application.
• Backend Testing using SQL queries on SQL Server tables and generating reports to ensure data integrity.
• Experiences working in ANSI x12 EDI transaction.
• Validate the date from EDI transaction.
• Tested the HIPAA EDI, 834, 270/271, 276/277, 837/835 transactions according to test scenarios and verify the data with Facets on different modules.
• Documented the test results and reported the status of assigned test tasks and issues to QA Lead.
• Administered benefits and processed healthcare claim payments using FACETS system.
• Conducted Back-End Testing Using SQL queries.
• Extensively used SQL statements to query the Oracle Database for Data Validation and Data Integrity.
• Track and report bugs using Rational Clear Quest.

Environment: Oracle, SQL, SOAPUI,UNIX,ASP.NET,C#, HIPAA EDI, X12, XML, QTP, Rational Clear Quest, Windows XP.

Confidential, Atlanta, GA

QA Analyst

Responsibilities:

• Involved in writing Test Plan and making sure that the development of test plan is according to the requirements.
• Involved in Back End Testing by extracting flat files from the server, which were generated by a Batch process to verify data against expected results
• Reviewed test assignments, developed test plans and scripts, and conducted test as assigned.
• Used Microsoft excels to write test case and exported to Rational Clear Quest.
• ValidateEDI Claim Process according to HIPAA compliance.
• Involved in testing HIPAA Database, which incorporates all the HIPAA (Health Insurance Portability and Accountability Act) transaction sets.
• Validated the translated HIPAA files with the proprietary CCR (Common Claim Record) implementations.
• Tested data to check HIPAA- eligible & participation check for individual coverage.
• Involved in creating test scripts and test data files for the HIPAA transaction based on the ANSI X12N HIPAA standards.
• Performed Functional testing using QTP.
• Used Visual Basic for ASP.NET debugging and White box testing.
• Inserted various check point using QTP, to measure the performance.
• Conducted result analysis and interacted with developers to resolve bugs.
• Assisted in UAT (User acceptance testing) testing.
• Performed regression, system testing and end-to-end testing of the application.
• Involved in GUI and functional testing of the application.
• Created Complex SQL Scripts and embedded them into Unix Shell Scripts to perform the back end testing.
• Tested and validated the database tables using SQL queries and Stored Procedures and performed Data Validation and Data Integration.
• Track and managed bug using Clear Quest.
• Participated in Status Review Meetings.

Environment: HIPAA, EDI, QTP,SOAPUI, Rational Clear Quest, SQL, GUI, Oracle, HTML, XML, Java, WINDOWS XP, Oracle, UNIX, Apache.

Confidential, Boston, MA

QA Tester

Responsibilities:

• Analyzed system test requirements and functional specification, involved in preparing Test Plans and Test cases and managed them using Quality Center.
• Performed Manual Testing and Involved in Functional, Positive, Negative Usability and Regression Testing for UAT (User Acceptance Testing).
• Performed backend testing by inserting data base checkpoints.
• Preparing defect reports and interacted with developers for debugging of the system Functionalities
• Preparing weekly status reports on the progress for management reviews.
• Tested and validated functionality of new screens for customized applications.
• Responsible for weekly status updates showing the progress of the automation testing efforts and open issues to be resolved.
• Performed GAP Analysis.
• Performed extensive manual testing before doing the automation.
• Involved in Functional, Integration and Regression Testing.
• Used SQL to query the database for Data validation.
• Used Quality Center to log defects and monitored the defects for successful resolution.
• Documented the complete test process and results with screen shots and Excel spreadsheets.
• Executed test cases and verified the actual results against expected results.
• Generated weekly status reports to the team manager and attend the weekly status meeting with Technical team, Team managers, and Business analysts.

Environment: Java, J2EE, Quick Test Professional 9.0, Mercury Quality Center