SUMMARY:

• More than 8 years of experience in software Validation, Technical Documentation, Quality Assurance as a Validation Engineer and Quality Analyst.
• In depth knowledge of SDLC - Software Development Life Cycle and various methodology such as Agile, Waterfall model, V model.
• Well versed with all stages of validation and testing of application
• Hand on experience of 508 - compliance & Regulation.
• Strong experience with development and reviewing of Validation Deliverable such as Validation Master Plan, Requirement Traceability Matrix, Validation Protocols (IQ, OQ, PQ), Validation Summary Report.
• Expertise in creation and execution of UAT, ATE & End-to-End system test scenario.
• Strong hands on database query creation and debugging of SQL Script.
• Hands on experience of reviewing User Requirement Specification (URS) and Functional Requirement Specification (FRS).
• Proficient in creating and maintaining Validation Matrix along with Qualification Documents, Validation Status Report.
• Strong experience reviewing, developing and executing Test Plans, Test Cases, Test Scripts, Test Scenario, Work flow Diagrams
• Hands on experiences with Automation tool such as HP ALM, HP Quick Test Pro, and Selenium IDE.
• Expertise in preparation of Defect summary report.
• Hands on experience with Application Life Cycle Management (ALM), HP Quality Center.
• Thorough knowledge of Corrective and Preventive Action reporting, handling and closing using software system like track wise.
• Experience in Defect tracking from Test protocol using ALM - defect module.
• Strong experience of Database Testing using various joins in SQL Queries.
• Thorough knowledge of various phases of Validation Life Cycle.
• Expertise in System testing, Integration Testing, smoke testing and Regression Testing.
• Capable to work independent as well as team player.
• Excellent interpersonal communication and writing skill.

TECHNICAL SKILLS:

Test Management Tools: JIRA 6.4, HP ALM 11.0, HP Quality Center 8.2/9.2, and Version one

Automation Test Tools: HP Quick Testing Pro 9.2/ 11, UFT 12, Selenium IDE 2.27

Graphical User Interface: MS window, Visual Basic

Defect Tracking tool: JIRA 6.4, ALM 11.0

Web Technology: HTML, .NET, beyond Compare 4.0

508 compliance tool: Dragon, Jaw, Magic

Web Service tool: SOAP UI

PROFESSIONAL EXPERIENCE:

Confidential, Wilmington, Delaware

Sr. QA Analyst

Responsibilities:

• Execution of Cross browser test protocol for static and transit web module as part of Team Hydra & Orion.
• Performed 508 ADA compliance by creation and execution of JAWS and Magic test cases.
• Assistance to business development team by providing live UAT.
• Execution of regression test cases and creation of defect and tracking status using JIRA.
• Created Testing Deliverable like Test Plan, Test Cases, Requirement Traceability Matrix and Testing Strategy.
• Creation of functional test case, End-to-End test case, and smoke test for QA2 & QA4 build based on specification as part of Agile Team.
• Updated version one sprint story status and progress flow as well as issue/defect tracking for each sprint cycle.
• Verification of metadata and sitecate by inspecting page source and page element.
• Creation of functional test case, End-to-End test case, and smoke test for QA2 & QA4 build based on specification as part of Agile Team.
• Thorough mobile device voice over testing for I-phone, I-pad & android device.
• Analysis of supported browser version and report maintenance for every month.
• Creation of test script using java script for Casper JS automation.
• Execution of Test protocols using test automation tool HP ALM.
• Document comparison and verification using Beyond Compare 4.0.
• Smoke test execution on Development build and reporting build verification status.
• Database record retrieval and verification as per UI information by creating & executing SQL query.
• Debugging existing automation script using UFT.
• Updating data table and deleting duplicate record using Delete/Update - SQL query.
• Open an account scenario creation & enhancing script using Selenium IDE.
• Terms & Condition PDF verification and defect reporting using Notepad ++.
• Discussed project status in weekly COP meeting and process review meeting and reported Test execution results.

Environment: ALM 11.0, JIRA 4.0, AngularJS, JavaScript, HTML, JAVA, Oracle10g, UFT 11.0, Selenium IDE, Beyond Compare 4, JAWS, MAGIC, Casper JS

Confidential, Gwynn oak, MD

Sr. QA Analyst/ Validation Analyst

Responsibilities:

• Detail gap analysis of requirement and verification of scoping for case request IPT.
• Creation of functional test case, End-to-End test case, and smoke test on development build based on specification as part of Agile Team.
• Experience with leading short team 3-4 member for Test Execution and Defect reporting
• Execution of Test protocols using test automation tool HP ALM
• Creation of Defect and tracking status using Version one.
• Updated of Defect and Test Case Status execution in Version 1 tool at the end of each sprint.
• Performed 508 - federal regulation compliance verification using MAGIC, JAWS tool.
• Created 508 test cases and execution as per guideline for 508 compliance - Dragon
• Smoke test execution on Development build and reporting build verification status.
• Performed functional test for NVF interaction with DCPS using SOAP UI.
• Database Record retrieval and verification as per UI information by creating & executing SQL query.
• Updating data table and deleting duplicate record using Delete/Update - SQL query.
• Test data - risk assessment and manipulation as per request from Validation team using execution script.
• Assistance to development team for re-verification of scenario in pre-development environment.
• Creation SIT scenario as per system requirement for Task Request module.
• Verified requirements mapped with existing test cases and ensured requirement traceability matrix.
• Execution of Automation script for filling test data as well NDDSS data cleanup using HP QTP.
• Performed document scanning and batch sending using FECS tool.
• Security testing for Task Request related to each Primary function.
• Creation of Validation report for the ongoing test activities.
• Performed Data migration and post migration verification activity for various releases.
• Test Data creation and maintained in mainframe and EDCS application.
• Provided support on System Test for End-to-End scenario, Flow charts and extensive Documentation and Reporting.

Environment: HP ALM 11.0, Version One, IBM DB2, HP Quality Center 10.0, JIRA, SOAP UI, Rational Requisite Pro, HP QTP 11.0, Mainframe system, EDCS, FECS user interface tool, DMA, JAWS, MAGIC, DRAGON

Confidential, Mason, Ohio

Validation Analyst/ QA Analyst

Responsibilities:

• Worked closely with Technical team and Business Analyst for review User Requirement Specification and Functional Requirement Specification.
• Reviewed Validation Deliverables throughout the entire Validation Lifecycle of the Adverse Event Reporting System (AERS).
• Developed Validation deliverable such as Requirements Specification, CSV Risk Assessment, Validation Plan, Qualification Documents, Requirement Traceability Matrix, Test plan, Test Summary reports.
• Involved in creation of Standard operating procedure as per the industry guideline.
• Assisted for developing Validation Master Plan for Oracle Adverse Event Reporting System as per the compliance guideline.
• Strictly followed SOPs and industry best practice for the Validation Life Cycle Phase.
• Created all Testing Deliverable like Test Plan, Test Cases, Requirement Traceability Matrix and Testing Strategy.
• Reviewed and Prepared Qualification Protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Executed Installation Qualification, Operational Qualification and Performance Qualification during Validation Life Cycle.
• Verified Functional requirements for Graphical User Interface of the AERS Study module using the Rational Requisite pro.
• Coordinated the validation activities to reduce protocol execution time and to meet project milestones.
• Assisted in planning, implementing as well as documenting user acceptance testing during the validation life cycle.
• Thoroughly used HP Quality Center to track, analyze and create defect report for Test script.
• Performed back end testing for the Oracle database by pulling SQL Script.
• Created Change request using Track wise software, Assisted in Back up and performance Monitoring and structured Change control Procedure for validated AERS.
• Developed Validation registry and Overall Test Summary Report and provided to management for review and approval.
• Provided Weekly Status Report for the project as per the management requirements.

Environment: AERS, Unix, HP Quality Center, Oracle 8.0i, Visual Basic 6, HP Quick Test Pro10.0, Window 2000, ASP, HTML

Confidential, LA, California

Validation Engineer/ QA Tester

Responsibilities:

• Participated in preparing SOPs for the Administration and Security for the validation of LIMS.
• Developed, analyzed, reviewed and summarized Validation Documentation, Test method Data, Specification Changes.
• Developed Validation Master Plan flow chart, which synthesized activity and shorten project completion time.
• Developed Validation Protocols such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Plan, Validation Registry, Test Execution Report.
• Analyzed User Requirement Specification and wrote Test Cases and Test Script for Operational Qualification and Performance Qualification for LIMS.
• Executed Graphical user Interface Testing to verify Functional requirement and Regression testing using the HP Quick Test Pro and prepared execution test report.
• Actively executed test script for Functional, Regression and Integration manually as well as Automation
• Created Test Execution Report as per the compliance requirement.
• Executed Performance Qualification in the Production Environment and verified User Requirements.
• Developed and maintained Requirement Traceability Matrix to reflect any changes in qualification and requirement specification documents.
• Worked on Deviation investigations, Quality System development, Documentation Control and Equipment Qualification as per the compliance requirement.
• Worked on Change Request to implement changes in the validated system as per the Change Management Process to determine impact of any changes on Validated Laboratory Information Management System.
• Traced, analyzed defect and generated bug report using HP Quality Center.
• Extensively performed backend database testing using SQL Queries.
• Created and maintained Validation Registry and Validation Summary Report.
• Thoroughly used MS word and MS Excel and PowerPoint for the presentation, Graphs, Flow charts and extensive Documentation and Reporting.
• Attended Status meeting and provided project status every week.

Environment: Window 2000, SQL-server, LIMS, ASP, Visual Basic, HP Quality Center 9.2, HP Quick Test Pro9.2

Confidential

Validation Engineer/ QA Tester

Responsibilities:

• Attended Status meeting and provided project status every week.
• Facilitated Failure Mode and Effects Analysis for EDMS to identify associated risk to the system and provided Remediation strategy plan.
• Performed Gap analysis to rectify the gap of the current system and implemented Change Control Process as per the Change Control Management System.
• Reviewed User requirement specification and Functional Requirement Specification for EDMS by interacting with Business and Technical team.
• Reviewed Computer System Validation Protocol such as Validation Master Plan, Validation Summary Report, Qualification Documents, Requirement Traceability Matrix).
• Responsible for writing Test Case and Test Scripts for the Installation Qualification (IQ) and Operational Qualification (OQ) as per the FDA Guideline.
• Created Test Plans, Test Scenarios and Detailed Test Cases based on the Use case documents, Business requirements and Functional Specification.
• Developed and maintained Requirement Traceability Matrix to verify requirement are being met during Test Execution Phase.
• Assisted in technical writing of the User Manuals for the EDMS application as per compliance requirement.
• Executed data-driven testing for the E-signature verification using HP Quick Test Pro by pulling different values from external file (Excel).
• Extensively used SQL queries to perform Back-end database testing using SQL Management Studio 2008.
• Assessed 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures to access data security issues like authorization and login.
• Developed Business Continuity plan and reviewed Disaster Recovery plan.
• Worked for planning, implementation and documenting User Acceptance Test cases and Test Scenario.
• Drafted Requirement Traceability Matrix to trace back Requirement with test cases.
• Assisted in development of Validation Summary Report and concluded all deviation as per FDA guideline.
• Discussed project status in weekly Project meeting and process review meeting and reported Test execution results.

Environment: Windows 2000, EDMS, HP Quality Center 8.2, MS office, Bugzilla, Visual Basic, .NET, SQL Management Studio 2008, HP Quick Test Pro 8.2