SUMMARY:

• Diversified experience in IT industry in a variety of roles including Software Quality Assurance Testing/Validation/Analysis. Proven experience writing, editing validation documentation. Experienced with SDLC, CSV, 21 CFR Part 11, GCP/GMP/GLP standards.
• Experience / Knowledge in CARES, and Argus Safety Systems. Has strong interpersonal skills and flair for learning new technologies. Has an ability to work independently with minimum supervision. Has good experience working in team environment. Experience in writing Oracle SQL statements.

TECHNICAL SKILLS:

Software: Test Director, HP Quality Center, QTP, WinRunner, Bugzilla, CearQuest

Languages: HTML, Java, Visual Basic, C, SQL, PL/SQL, COBOL

EDMS & Front Office: Documentum, Epic Star, SharePoint, Trackwise, MS Office, MS Outlook, Lotus Notes, Visio, MS Project

Database: Oracle, SQL Navigator, MS Access, Sybase, SQL Server

Operating Systems: Windows (3.x, 95, 98, 2000, NT, XP, Vista, 7), MS - DOS, UNIX

WORK EXPERIENCE:

Confidential, Raritan, NJ

Sr. Validation/Compliance Analyst

Responsibilities:

• Reviewed URS and FRS and provided suggestions and comments
• Assisted in developing the Compliance Plan, Master Test Plan, Compliance Report, System Test Protocol, System Test Report and FMEA
• Developed Requirements Traceability Matrix
• Uploaded user and functional requirements in HP ALM and created the linkage. Linked requirements to test scripts in HP ALM
• Reviewed pre-execution and post-execution system test scripts and provided comments
• Provided direction for UAT script writing and reviewed UAT scripts

Environment: HP ALM 12, SharePoint, MS Office 2007, Internet Explorer, Adobe Acrobat Professional / Reader 11.x

Confidential, Peapack, NJ

Validation/Compliance Analyst

Responsibilities:

• Reviewed Requirements Specification documents and provided comments.
• Developed Test Plan, Test Scenarios, Test Scripts, Requirements Traceability Matrix.
• Has worked closely with team members and business group in order to meet group and organizational goals.
• Participated in peer review of test scripts and provided feedback. Executed system test scripts as part of system validation activities.
• Used HP Quality Center for test management.

Environment: HP Quality Center 10, SharePoint, MS Office 2007, Documentum, Internet Explorer

Confidential, Pennington, NJ

Sr. QA Analyst

Responsibilities:

• Involved in all the phases of testing from end to end. Primary responsibilities included, Requirements review, Test Planning, Test Execution, Defect Reporting & Tracking, Functional Automation to support regression, Performance Analysis to meet response time requirements and conduction UAT & PVT.
• Responsible for testing the Advisory platforms WMW Band, Patriot Band and call center platforms for Retirement Services, FRS & IRCC on (XP) and WMCS and RBCC on (BAND) 7.
• Worked closely with Business, Engineering team, Deployment team in understanding the requirements and resolving the issues.
• Performed Business functionality testing, Regression testing, Target Testing and End to End testing of the application for various release cycles.
• Used Quality Center for test script creation, execution, defect management, and generating dashboard reports for senior management.

Environment: HP Quality Center 11.0, QTP 11.0, SharePoint, Java, MS Office 2007, Internet Explorer

Confidential, Hopewell, NJ

Sr. Validation Analyst

Responsibilities:

• Reviewed Requirements, Field Mapping, Code List Mapping and Migration Plan documents.
• Performed dry runs in the development and testing environments for migrated cases to validate CIOMS & MedWatch reports and ARGUS to CARES screen comparisons.
• Verified that the (non-PII fields) data of Clinical Trial cases is migrated from LSS ARGUS to BMS CARES as per the transformation logic specified in Field Mapping Specification.
• Verified the accuracy and data integrity of migrated data by comparing regulatory reports (CIOMS & MedWatch) generated for identified sample cases from LSS and CARES applications.
• Performed a defect manager role during formal OQ execution phase.
• Worked closely with QA during pre and post script execution review and also during defect review process.
• Worked closely with team to address QA review comments on scripts and defects.
• Responsible for SME approval of pre and post script execution.
• Responsible for developing Requirements Traceability Matrix and Validation Summary Report.
• Used Quality Center for test script creation, execution, defect management, and generating dashboard reports for senior management.

Environment: HP Quality Center 10.0, SharePoint, Java, MS Office 2007, Internet Explorer, Oracle, SQL Navigator

Confidential, Pennington, NJ

Sr. QA Analyst / Quality Center Support

Responsibilities:

• Responsible for creating Test Plans and detailed Test Cases based on Design documents and Requirements Specification documents. Responsible for uploading test scripts from Microsoft Excel to Quality Center.
• Participated in GPC Code Defect Meetings with Release Manger and developers in resolving the defects investigated in the application during testing. Used Quality Center for Defect tracking. Performed regression testing after the bug fixes.
• Performed Health Check Testing of all core applications by running the automation scripts in Quality Center and sending the status to all teams.
• Created the Ad-hoc test scenarios while testing the releases. Executed SQL queries to verify the data.
• Responsible for coordinating with the Off-shore team in India and trained them with new applications.
• Responsible for adding users to different Quality Center projects. Assisted users in resolving Quality Center questions/issues.
• Assisted users in resolving QC login/access issues by resetting passwords and upgrading user roles.
• Created new data fields in QC and added new data values to the existing fields.
• Responsible for Test Lab and Defects module workflow code customization. Involved in HP Quality Center migration testing. Generated reports for senior management by running queries in Quality Center.

Environment: HP Quality Center 9.2, 10.0, Clear Quest, Sharepoint, SQL, Java, C++, MS Office 2007, Internet Explorer

Confidential, Raritan, NJ

Sr. Validation Analyst

Responsibilities:

• Responsible for analysis and review of user requirements specification, work instructions and system test protocols.
• Responsible for preparation of the source documents and converted them to PDF and signed using the Johnson & Johnson digital signatures.
• Responsible for reviewing Validation plan and executing test cases for Adobe digital signature validation.
• Created and validated digital signatures on Microsoft Windows Operating systems, limited to, Windows XP, Windows Vista, Windows 7 32-bit and Windows 7 64-bit
• Identified defects within the software and clearly documented test incidences and deviations.
• Ensured that all original validation documentation is packaged for official archival at the conclusion of the work completed for each release.
• Involved in using SharePoint for day-to-day project related documentation.

Environment: Adobe Acrobat Professional / Reader 9.x, MS Office 2007, Sharepoint, Windows XP, Windows Vista, Windows 7 32-bit, Windows 7 64-bit

Confidential, Pennington, NJ

Sr. QA Analyst / Quality Center Support

Responsibilities:

• Responsible for creating Test Plans and detailed Test Cases based on Design documents and Requirements Specification documents.
• Responsible for uploading test scripts from Microsoft Excel to Quality Center.
• Responsible for GPC Code Defect Meetings with Release Manger and developers in resolving the defects investigated in the application during testing. Used Quality Center for Defect tracking. Performed regression testing after the bug fixes.
• Responsible for Health Check Testing of all core applications by running the automation scripts in Quality Center and sending the status to all teams.
• Created the Ad-hoc test scenarios while testing the releases. Executed SQL queries to verify the data.
• Responsible for coordinating with the Off-shore team in India and trained them with new applications.
• Responsible for adding users to different Quality Center projects. Assisted users in resolving Quality Center questions/issues.
• Assisted users in resolving QC login/access issues by resetting passwords and upgrading user roles.
• Responsible for creating new data fields in QC and adding new data values to the existing fields.
• Responsible for Test Lab and Defects module workflow code customization. Involved in HP Quality Center migration testing.
• Generated reports for senior management by running queries in Quality Center.

Environment: HP Quality Center 9.2, 10.0, Clear Quest, Sharepoint, SQL, Java, C++, MS Office 2007, Internet Explorer

Confidential, Peapack, NJ

Sr. Validation Analyst

Responsibilities:

• Reviewed SOPs, Design document and Requirements Specification documents.
• Developed Validation Plan, Validation Scenarios, Validation Scripts and Validation Summary Report.
• Responsible for execution of validation scripts during Commissioning phase.
• Worked closely with developers and team members in order to meet group and organizational goals.
• Identified defects within the software and notified application developers. Clearly documented test incidences and deviations in testing for future s.
• Executed Documentum DQL queries for verifying data.
• Analyzed and documented test result outputs for correctness and completeness.
• Responsible for routing all documentation for review and approval using Documentum, and addressing review comments.
• Responsible for leading the validation effort for Caguas Puerto Rico Data Migration release.
• Responsible for creating and maintaining Requirements Traceability Matrix.
• Performed the QA review of Validation documents and reports for other releases.
• Conducted User Acceptance Testing in user environment to provide end user with confidence that the software is ready to be used.
• Involved in using SharePoint for day-to-day project related documentation.
• Responsible for validating PfLICC Change Requests. Used Trackwise for entering Change Requests.

Environment: Documentum, Windows XP, MS Office Suite, Sharepoint, Trackwise, Adobe Acrobat, Bugzilla version 2.22.4, Internet Explorer

Confidential, Hopewell, NJ

Sr. Validation Analyst

Responsibilities:

• Performed verification of system functional design and Requirements Analysis which included Use Case documents and Enhancements and Defects (ER/DR) Requirements.
• Created System Test and UAT Test Plan documents that define the test environment, phases of testing, timelines for different phases of testing, entrance and exit criteria into different phases of testing, test scenarios and test scripts based on Use Case documents and requirements specifications.
• Responsible for leading CARES major and minor releases. Determined the scope of testing by using release documentation and set test objectives for System and User Acceptance Testing of the releases, accurately estimated testing effort for release, managed resource allocation throughout testing cycle and successfully deployed release based on projected schedule.
• Developed and maintained test cycle release documentation that included Release Plan, System and UAT Test Plan, Validation Plan and Summary, System and UAT Test Scenarios, IQ/OQ/PQ Test Scripts, Testing Status, Requirements Traceability Matrix, and Issue Reporting forms.
• Developed Regression test scripts, and performed regression test after the bug fix.
• Has worked closely with developers, QA Advisor, team members and business group in order to meet group and organizational goals.
• Reviewed other team members scenarios and scripts and provided feedback. Executed system and user acceptance scripts as part of system validation activities.
• Executed Oracle SQL queries for verifying data.
• Identified defects within the software and notified application developers. Clearly documented test incidences and deviations in testing for future s.
• Conducted User Acceptance Testing in user environment to provide end user with confidence that the software is ready to be used.
• Used Epic Star for document routing and approvals.
• Ensured that all original validation documentation is packaged for official archival at the conclusion of the work completed for each release.
• Responsible for working with the CARES Administration group and end-users in trouble-shooting production issues that arise with the CARES application.

Environment: Java, J2EE, PL/SQL, XML, Oracle9i, Windows XP, Internet Explorer, Epic Star

Confidential, East Hanover, NJ

QA Analyst/Technical Writer

Responsibilities:

• Developed Test Plan, Functional Requirements Specification, System Test Specification, and Summary Report
• Developed IQ, OQ & PQ test scripts based on SDS and FRS.
• Performed validation tests by executing the scripts to insure that the developed functionality meets the specifications prior to UAT testing.
• Executed Oracle SQL queries for verifying data.
• Analyzed and documented test result outputs for correctness and completeness.
• Identified defects within the software and notified application developers.
• Developed Regression test scripts, and performed regression test after the bug fix.
• Conducted UAT in user environment to provide end user with confidence that the software is ready to be used.
• Supported the Project Manager in developing Quality Plan, Functional Risk Analysis for all PharmOps applications, migration of all US PharmOps owned applications from their existing operating systems to Windows XP environment.
• Helped Package Builders in Packaging (installing applications under XP environment and checking the functionality).

Environment: Oracle 8i, Windows NT, Windows XP, Lotus Notes, Visual Basic, Power Builder, Internet Explorer, Java, HTML

Confidential, Rahway, NJ

QA Analyst

Responsibilities:

• Responsible for creating test plans, test specifications and test summary reports based on Functional Requirement Specifications and System Design Specifications.
• Responsible for developing/executing test procedures to ensure that clinical trials and data generated from them are in compliance with Good Clinical Practice.
• Performed back-end testing by executing adhoc queries using SQL.
• Worked closely with developers to resolve the defects investigated in the application during testing.
• Participated in checking the performance of applications by doing performance testing.
• Performed regression testing on successive releases. Executing Validation test script as per need (which is automated by WinRunner).
• Performed Performance Testing using Load Runner. The Average CPU usage, Response time are analyzed for each scenario.
• Participated in peer review of documentation to make sure all the documentation is properly completed and there are no open issues.
• Performed User acceptance testing on completion of integration testing before installation of the application on user environment.

Environment: Visual Basic 6.0, Oracle8i, EDMS, Windows NT, Windows XP, TestDirector 7.2,Unix, Java, HTML, MS Office, WinRunner, Load Runner, Internet Explorer 5.5, Netscape Communicator 4.6

Confidential, Plainsboro, NJ

QA Analyst

Responsibilities:

• Analyzed test plan and developed test cases based on technical specifications and business requirements.
• Performed manual testing and data integrity/back end testing by executing SQL statements.
• Interfaced with developers in resolving the defects investigated in the application during testing. Performed regression testing after the bug fixes.
• Responsible for code migration process, which is a process of migrating code to appropriate servers after the code is changed for enhancement or bug fix.
• Responsible for updating the change log. Change Log is an excel spreadsheet used for entering the changes done to the data mart applications.
• Performed Data Mart balancing which is nothing but balancing consumer meds data with SAP data.

Environment: Visual Basic, Power Builder, Java, HTML, Cognos Impromptu, Powerplay, Unix, Oracle, MS Access, NT, Novell NetWare, IE 5.5

Confidential, Rahway, NJ

QA Analyst

Responsibilities:

• Responsible for creating test plans, test specifications and test summary reports based on Functional Requirement Specifications and System Design Specifications.
• Responsible for developing/executing test procedures to ensure that clinical trials and data generated from them are in compliance with Good Clinical Practice.
• Performed back-end testing by executing adhoc queries using SQL.
• Worked closely with developers to resolve the defects investigated in the application during testing.
• Participated in checking the performance of applications by doing performance testing.
• Performed regression testing on successive releases. Executing Validation test script as per need (which is automated by WinRunner).
• Performed Performance Testing using Load Runner. The Average CPU usage, Response time are analyzed for each scenario.

Environment: Visual Basic 6.0, Oracle8i, EDMS, Windows NT, Windows XP, TestDirector 7.2,Unix, Java, HTML, MS Office, WinRunner, Load Runner, Internet Explorer 5.5, Netscape Communicator 4.6

Confidential, Stamford, CT

QA Tester

Responsibilities:

• Developed test cases based on the technical specifications and business requirements and modifying scripts for GUI automation.
• Analyzed and modified test plans and test specs according to the new releases.
• Wrote SQL statements to perform data integrity testing.
• Documented software defects and wrote modification requests.
• Developed test procedures and test cases for Regression testing after bug fixes.
• Performed manual and automated testing including functionality, GUI, and user acceptance testing on client/server environment.

Environment: Delphi, Visual Basic, Oracle, Sybase, Windows NT, WinRunner, Internet Explorer 5.5, Netscape 6.0, Java, and HTML

Confidential, NY

Developer/Tester

Responsibilities:

• Designed and Developed Business Engine user reports in MS Access.
• Created and implemented test plans and test scripts based on technical specifications and business requirements.
• Performed manual and automated testing including functional, front-end, performance, user acceptance and Y2K compliance testing on client server environment.
• Performed data integrity/back end testing by executing SQL statements.
• Documented errors, writing modification requests & their resolution and performed regression testing on the successive builds using SQA Robot.
• Performed User acceptance testing on completion of system testing before installation of the application on user environment.

Environment: MS Access95, Oracle 7.32, Windows NT, SQA Robot, Netscape Navigator, and Internet Explorer