SUMMARY:

• 8 years of experience in Software Development Life Cycle (SDLC) which involves requirement gathering, requirement analysis, development, implementation & maintenance of Projects as Sr QA Engineer and Sr. Analyst in Healthcare and Pharmaceutical domain.
• Hands on Experience with Designs, documents, implements procedures & techniques that are consistent with departmental SQA Methodology for analyzing, testing, and evaluating the risk (software & business), accuracy, completeness, internal integrity/consistency, testability and overall quality of business systems and SDLC processes.
• Expertise on IT Service Management software tools like JIRA, Tem Foundation Server (TFS), Microsoft Team Manager (MTM) & IBM Rational ClearQuest for Test Report preparation, defect - tracking & reporting purposes.
• Hands on experience on process improvement methodologies such as Agile, LEAN, Six Sigma, TQM, Waterfall etc.
• Excellent knowledge of industry standard methodologies like Software Development Life Cycle (SDLC), Software Test Life Cycle (STLC), Product Lifecycle Management (PLM), Waterfall, Iterative Software Development Life Cycle Process as per LEAN, Six Sigma, Agile - Scrum/Kanban (Sprint Planning, grooming, stand-ups, team communications and Review).
• Involved in all aspects of the Software Test Lifecycle (STLC), for example, requirement analysis, test planning, test case development, test environment set-up, test execution, maintain RTM and testing closure to ensure all deployed code meets business needs.
• Involved in Computer Systems Validation (CSV) according to FDA Guidelines, GxP (GLP, GCP, GDP & GMP), cGMP and 21CFR Part 11.
• Involved in develops & audit validation lifecycle documentation like batch records, log books, Clinical Study Report, Validation Plan, Risk Management Plans, Operational SOPs, Change Controls, Deviation, CAPAs, User Requirement documentation (BRD) /Functional Requirement documentation (FRD) / Software Design Specifications requirement (SRS), Traceability Matrix, IQ, OQ and PQ protocols, summery reports etc.
• Perform Mobile testing to ensure the software works on the Android / iOS / Windows smartphone applications.
• Involve in writing SQL scripts to extraction, cleansing and modification of data from various data sources like flat files, X12 format files and databases.
• Handling DHCS and CMS enrollment, disenrollment & claims adjudication process, and also IPA Authorization.
• Expertise in project management with Healthcare HIPAA operations and analytics professional ANSI ASC X12 transitioning into 834s, 837s, 835, 270/271, 276/277s, 999s, 277CA, & also DTRR, BEQ, 4RX & HCO.
• Involve in prepared all status reports and related project documentation including project issue log and risk mitigation.
• Followed Agile Methodology to emphasize on real-time communication over written documentation. Involved in Black Box, Positive, Negative, Data-driven, System Integration, System Regression, End to End, Functional, Smoke/Sanity, Static, Exploratory, Interface, SIT, UAT & Modal Office Testing.
• Performed UNIX commands to Parse X12 834 files and covert to Pipe Delimited (CSV) file to load to SQL tables.
• Developed SSIS package to load Proprietary and ASC X12 format files to SQL tables for the process of testing Data Quality and Integrity.
• Facilitate JAD sessions & Rapid Application Development (RAD) while working in waterfall & Agile environment for communicating with the all impacted team members including Project directors, Managers and stakeholders to communicate their perspectives, find the ideas to resolve the issues, prioritize the tasks, and reach agreements & activities throughout all stages of SDLC.

TECHNICAL SKILLS:

Operating Systems: Win95, 98, 2000/XP/2003 Server, DOS, iOS, Android, Blackberry¸ Windows and UNIX

Languages: C, C++, Java, SQL, .Net

Database: Oracle, DB2, SQL Server, MS Access, Mongo DB

Testing Tools: SoapUI and Selenium, Benefit File Manager (BFM), POSTMAN

Defect Tracking Tools: JIRA (ITSM tool), Clear Quest (IBM Rational), MS Excel (Microsoft), Trackwise (QMS), Team Foundation Server (TFS) & Microsoft Team Manager (MTM)

Utilities: MS Word, Excel, Access, PowerPoint

SDLC and QA Methodology: Agile, LEAN, Six Sigma, TQM, Waterfall, Agile (Scrum/Kanban)

Modeling Tools: Erwin, Rational Rose, MS Visio

PROFESSIONAL EXPERIENCE:

Confidential, Rancho Cucamonga, CA

Sr. QA Engineer

Responsibilities:

• Involve in different stages of project implementation layers activity, such as: SDLC methodologies, system integration, data mapping, QA processes, Relational Databases, and development processes.
• Responsible for a leadership role on EDI IT projects as well as Modal Office (production) support releases.
• Review the data models, maps and documents to ensure that the design solution meets the requirements.
• Responsible for the successful gathering, understanding, analyzing, clarifying and documenting of operational business requirements of the projects to address the Stakeholders needs and also ensure correctness and quality of delivery.
• Collaborates with Project Sponsors to develop test strategies and plans for large/complex projects, making recommendations, and ensuring that project risks are mitigated by facilitating Scrum meetings.
• Facilitating Scrum ceremonies, grooming, estimation & teams communications, stand-ups, track backlog of tasks & report status of sprints.
• Validating data, schema structure, mapping, and layout at HIPAA 5010 compliance according to companion guide & implementation standard for HIPAA 5010 ASC X 12 and Flat Files.
• Expertise in project management with HIPAA 5010, Flat files & ANSI ASC X12 transactions 834 I/O, 837P/I, 277, 999, TA1, 277CA and 835.
• Write SQL queries to investigate, validate and verify the data integrity of Proprietary files and X12 Files to be sent to Trading Partners/Stakeholders.
• Coordinates with Business users to develop function application requirements and detailed system requirements to IT team members, project team members, and other project managers and analysts.
• Work closely with Business to development of business process and technology to support Claims/encounters, Care Management and Risk Adjustment for Medicare & Medi-Cal LOBs according to DHCS and CMS rules.
• Creates and maintains SQA deliverables including test strategy, test plans, test scenarios, test criteria, test data, test cases, project test progress and release reports, application turnover/Sign Off documents and test schedules suitable for a variety of IT projects to effectively test configured software and custom-developed IT applications.
• Using UNIX commands to Parse ANSI X12 HIPAA transaction sets including X12 834, 835 and 837 files and covert to Pipe Delimited (CSV) files to load into SQL Server Database using MobaXterm application.
• Developed Visual Studio SSIS package to load Proprietary and X12 format 834, 835 & 837 files to SQL tables for the process of testing Data Quality and Integrity.
• Working Knowledge with Edifecs Suite- Spec builder, Notepad++ & UltraEdit test Editor Tools.
• Perform functional ‘Grey box’ testing of IT applications including defect identification & resolution.
• Work directly with project teams to effectively communicate and prioritize known issues and defects.
• Maintains libraries of application requirements, specifications, test cases, defect logs, and test results.
• Perform user acceptance testing (UAT) with business partners, ensuring that proper UAT is performed.
• Creating Test plan and Test summary documents according to SDLC & STLC standards and executed test plans using Team Foundation Server (TFS)/Microsoft Team Manager (MTM).
• Perform Mobile testing to ensure the software works on the Android / iOS / Windows smartphone applications & also the look and feel of software is simple, elegant and friendly for the users.
• Developed automated SQL scripts to retrieve data from tables, using various business logics, hierarchy, and priority and then validate with the Proprietary and X12 834s & 837s files to produce reports for Data fallouts.
• Develop SQL reports as needed to investigate system & Database related issues.
• Validating EDI systems & ANSI ASC X12 files (X12 834 & 837) including claims adjudication and enrollment processing at all snip level & tracking defects until completion to confirm deployed codes meet business needs.
• Proficient in testing Web Services application using POSTMAN.
• Collaborates with Confidential System Security Administrator to ensure that security standards are followed and that PHI data is not at risk of being compromised.
• Develops functional and detailed system requirements, sometimes independently, to ensure comprehensive and complete testing of applications.
• Develops and runs automated test scripts and evaluates results.
• Develop and maintain user instructions, operational instructions, process documentation, and program documentation according to IT group standards.
• Conducts SIT, Regression, UAT, End to End, Production, load, exploratory & application stress testing.
• Facilitates JAD & RAD sessions while working in Waterfall & Agile environment for communicating with the all impacted team members to communicate their perspectives, find the ideas to resolve the issues and reach agreements & activities throughout all stages of SDLC.

Environment: TFS, MTM, Jira, Share Point, EDI, ANSI ASC X12, Proprietary Format Files, Flay Files, SQL Server, MobaXterm, POSTMAN, Web Services, XML, Windows, Edifecs Suite- Spec builder, Oracle, TOAD, Visual Studio 2015, MS Office, Notepad++, UltraEdit, Rhapsody IDE, EDIMS, Terminals, EDI Editor, JIVE, Work Front, ETL Ascential DataStage (7.5)

Confidential, Detroit, MI

Sr. IT Analyst

Responsibilities:

• Responsible for the successful gathering, understanding, analyzing and documentation of operational business requirements of the projects to address the client’s needs and also ensure correctness and quality of business delivery.
• Analyze and Report Business requirements to determine the feasibility of applications within time and cost constraints and interacting between business (user) and development team.
• Analyze user functional requirements and translate them into system requirements and specifications for the development team.
• Involve in all aspects of the Software Development Life Cycle & Software Test Lifecycle, for example, requirement analysis, test planning, test case development, test environment set-up, test execution and testing closure to ensure all deployed code meets business needs.
• Responsible for facilitating the team level agile-scrum ceremonies including retrospectives to ensure continuous improvement from sprint to sprint by removing impediments and escalate issues to the management when needed.
• Perform business analysis and create detailed business requirements, current & future process flows, Gap analysis (AS-IS TO-BE), Requirement Traceability Matrix documents, etc.
• Excellent working knowledge of industry standard methodologies like Agile, Software Development Life Cycle (SDLC), Software Test Life Cycle (STLC), Product Lifecycle Management (PLM), Rational Unified Process (RUP), Scrum (Sprint Planning and Review) & Kanban.
• Create test plan and test summary documents according to SDLC standards Executed test plans.
• Creating and maintaining Requirement Traceability Matrix (RTM) based on Software Architecture Document (SAD) and Business Requirement Document (BRD).
• Extensive experience testing iOS, Android and Windows apps.
• Assure software delivered meets all requirements and expectations of final go-live plan.
• Engage in daily Defect Triage and Review meetings to discuss defects and project reports status and provided best solution approach througho­ut SDLC process.
• Involve in IT Service Management software tool like JIRA and Clear Quest IBM Rational tools for defect-tracking/investigation & reporting requests and tracking them to completion.
• Assist with the creation of the UAT Test Strategy, Test Plan, and execution schedule.
• Well versed with Test Report preparation, Defect Tracking & Reporting using IBM Rational Clear Quest.
• Involved in encounter data testing and validating HIPAA 834, 835 and 837 files where the data is pulled from DSN (Data Source Network) environment using SQL query tool and it is used as a source of truth for System integration testing and User acceptance testing.
• Execute test scripts and track defects for system Integration testing, regression testing, integration testing, database testing, performance testing, load testing etc.
• Working collaboratively within a project team environment to assist in the development & execution of end-to-end testing of telephony and infrastructure related projects like IVR.
• Knowledge of Automated Testing in SOAPUI and SAML.
• Prepare the test deck and test steps for the Self Service Applications based on the requirements and systems to impact.

Environment: RDBMS, SAS, JIRA, ClearQuest, NASCO Classic, MS Access, ePI, Facets 2.9, LDS, EDW, EPR, Mongo DB, NASCO, MongoDB, Xwalk, MOS, JavaScript, Kanban, Agile, Agile-Scrum, Oracle, DB2, Unix, Microsoft SQL Server, Windows 2000, Microsoft Excel and Microsoft Word, SharePoint

Confidential, Cranbury, NJ

Sr. QA Analyst

Responsibilities:

• Performed internal compliance and IT audits for Regulatory inspection preparedness.
• Experienced in the Testing and documentation of Validation Protocols for Instrumental, Operation and Performance Qualification by following V-Model life cycle.
• Involved in Computer Systems Validation (CSV) according to FDA Guidelines, GxP (GLP, GDP & GMP), cGMP and 21CFR Part 11.
• Created IQ/OQ/PQ Validation reports for LIMS 5.0 and Empower interface following V-Modal lifecycle.
• Involved in develops & audit validation lifecycle documentation like batch records, log books, Clinical Study Report, Validation Plan, Risk Management Plans, Operational SOPs, Change Controls, Deviation, CAPAs, User Requirement documentation (BRD) /Functional Requirement documentation (FRD) / Software Design Specifications requirement (SRS), Traceability Matrix, IQ, OQ and PQ protocols, summery reports etc.
• Validated the reports and files according to SDLC & STLC enforced standards.
• Involved in technical writing of test plans and executing Protocol.
• Reviewed requirements of System Users and QA personnel for functional, regulatory, 21 CFR Part 11 and configuration requirements.

Environment : V-Model, Empower, GAMP 5, Labware LIMS 5.0, 21 CFR Part 11, GDP, GLP, GMP, GxP, Agile- Scrum, cGMP

Confidential, Levittown, PA

Quality Assurance Analyst

Responsibilities:

• Prepared IT defect reports and provided status updates at weekly bug-tracking meetings.
• Provided governance and change management leadership for Software Quality Testing.
• Wrote test cases and test scripts for System Integration Testing (SIT) and User Acceptance Testing (UAT).
• Documented Requirements Traceability Matrix (RTM) and regularly updated it to map test cases to new requirements.
• Performed Computer Systems Validation ensuring 21CFR Part 11 compliance for cGMP & GxP.
• Interfaced with supplier and customer quality representatives concerning problems with quality assurance and assure that effective corrective action is implemented.

Environment : SQL, Agile, 21 CFR Part 11, GxP, cGMP

Confidential

Quality Assurance Analyst

Responsibilities:

• Production floor monitoring (IPQA) by reviewing in process printed and non-printed material.
• Responsible for communicating clearly issues in order to resolve them on time.
• Learn to get knowledge that our product will be made to the highest standards as required by the regulatory authorities.
• Learned to work with Research and Development on projects to determine product stability.
• Learned pathogen analysis, plating, media preparation, solids, nitrogen, yeast activity and physical characteristic evaluation.

Environment : HPLC, GC, MS Office, V-Model, 21CFR Part 11, cGMP, GMP, TLC, Dissolution, LCMS, GCMS, AAS, XRDNMR, CE, Particle size analyzer, GxP, Chromatography & Spectroscopy, USP, BP, EP, IP