SUMMARY

• 8 years of professional experience as a Business Analyst within the Pharma domain.
• Expertise in Software Development Life Cycle (SDLC) methodologies, assisting and working as Scrum Master on several projects, vast experience working in Agile, Waterfall, RUP, Spiral methodologies and got opportunities to put hands on all of them.
• Experience in Business and Functional Requirements gathering, expertise in developing Business Requirement document (BRD), Functional Requirement Document (FRD), Use Case Documents, and Business Rules Spreadsheets (BRS), Standard Operating Procedures (SOPs) and Software Requirement Specification (SRS) across the deliverables of a project.
• Expert in Tracing requirements throughout the development process and verifying adherence using the requirements Traceability Matrix (RTM).
• Experience in conducting Joint Application Development JAD sessions with SMEs, Business Analysts, Software Developers and Quality Assurance teams.
• Experience in conducting Requirement Workshops, JRD, GAP analysis, Impact, Cost - Benefit, System Design Document (SDD), UML Modeling, Analysis creating artifacts, created Use cases, sequence, activity diagrams.
• Expertise in managing multiple projects while maintaining constant communication with the relevant stakeholders.
• Expertise in the implementation of the Labware Laboratory Information Management System (LIMS) Project for Pharma Biotechnology.
• Experience in validating Laboratory Information Management System (LIMS).
• Experience in requirement elicitation, design, analysis, and maintenance of solutions facilitating business requests and in Performing EHR sales demonstrations for potential clients.
• Expertise in implementing a Pharmacy Benefits management (PBM) program using encrypted FTP data feeds.
• Experience in Clinical Trial Management System (CTMS) & Enterprise Data Management (EDM).
• Excellent experience in working with FDA regulated environment, GxP (GCP/GLP/GMP) guidelines.
• Experience in application 21CFR (Code of Federal Regulations) part 11, GxP and CSV guidelines.
• Expertise in UML methodology to create UML Diagrams including Use Cases Diagrams, Data Flow Diagrams (DFDs), Sequence Diagrams, RACI Diagrams, Activity Diagrams, ER Diagrams using Rational Rose and MS Visio and thus defining the Data Process Model and Business Process Model.
• Sound working knowledge on SQL Queries, Triggers, Stored Procedures, Indexes in SQL Server with a strong understanding of data & analytics.
• Tracking and Maintaining Stakeholder requested enhancements and changes through SharePoint.
• Experience in Building, publishing dashboards and customized interactive reports, report scheduling using Tableau server.
• Strong Knowledge on elaborating Billing Center configuration user story such as Delinquencies, Billing Parameters, Policy Cancellation, Invoicing rules, Policy Rewrites, Policy Reinstatements, Automated disbursements, Fees and Payment distribution rules.
• Proficient in using Version control tools, agile management tools like, RALLY, Git Lab and GITHUB.
• Strong Experience using Quality Management System (QMS)
• Hands On Experience In Track Wise, Jira, Confluence.
• Strong knowledge in regulatory compliance, GMP, Quality Assurance Audits, Document control, Quality Assurance/Quality Control activities in the pharmaceutical industry.
• Proficient in creating and executing UAT test cases, developing test plan, managing defect tracking, assisting Quality Assurance team.
• In-depth knowledge HP Quality Centre Test Management tool/ALM, Test Link and JIRA for creating and executing Test cases.
• Proficient in the use of, MS Word, MS Excel, MS Visio, Visual Studio as well as MS Project.
• Strong experience with Test Case Management using Mercury Quality Center.

PROFESSIONAL EXPERIENCE

Sr Business Analyst

Confidential - Chicago, IL

Responsibilities:

• Interacted with Business Owners, Users, and Stakeholders to identify Business system needs, evaluated solutions for business problems, and prepared Business Requirements Document (BRD) and later translated them into Functional Requirements Document (FRD).
• Involved in the Research and Development (R&D), Manufacture and Sale of a range of products which Confidential manufactures- Consumer, Pharmaceutical, and Medical Devices and Diagnostics.
• Organized and facilitated agile meetings as well as supporting the implementation of Agile scrum across all work streams to ensure continuous improvement.
• Followed UML based methodology using Rational Rose for creating Business Cases and Use Case Models after assessing the status and scope of the project and implementing technology based solutions that will meet their strategic business processes needs.
• Involved in validation of Labware LIMS and Open Lab including editing and review of protocols and post execution review for IQ (Installation qualification) and OQ effort.
• Involved in operational testing of Labware LIMS software and involved in writing of Operational Qualification of various LIMS modules.
• Collaborated with UX Designers for style consistency and setting design standards for client's wireframes.
• Performed UX/usability study to identify the user pain points and identify the improvement opportunities. Recommended certain changes to user flows and navigation of the website.
• Collaborated with the QMO Manager to define and establish the appropriate Quality Management System (QMS), based on project and client requirements; such as Capability Maturity Model Integration (CMMI), ISO 9001, Six Sigma, and Information Technology Infrastructure Library (ITIL)
• Worked with internal team, CROs and clinical sites to ensure the tracking and timely conduction of clinical studies.
• Assured that all the validation documentation such as IQ, OQ, PQ are in compliance with c GMPs.
• Performed Requirement Analysis to understand user needs for data Toxicology/ Pharmacology n-tier system.
• Coordinated with multiple clinical departments, IS Teams and vendors to gather requirements and implement application changes in support of department changes and new builds.
• Involved in conducting validation and configuration of LIMS module as per 21 CFR part 11 Compliance.
• Conducted manual testing like functionality, integration, system, positive and negative testing.
• Initiated and performed automated testing of AUT using Quick Test professional.
• Created transition requirement document to allow users to be familiar with new CTMS System.
• Performed validation of laboratory equipment like GC/MS, HPLC, Spectrophotometer and Autoclave in compliance with c GxP guidelines.
• Performed 21 CFR Part 11 GAP Analysis, Risk Analysis, Developed Requirements, Traceability Matrix (RTM) to track requirements for the software application module. Validated Lab Ware LIMS to meet 21 CFR Part 11 FDA Regulations.
• Involved in developing and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, CFR Part 210 and GxP GLP, GCP, GMP Compliance Regulations.
• Worked with project manager, SMEs and assisted with the implementation of the Labware LIMS
• Involved in documenting the Validation Master Plan in accordance with FDA regulations, particularly 21 CFR Part 11, GLP and GMP.
• Communicated LIMS Requirements to site/system owners and gained consensus with management, IT, QA and scientists of departmental requirements.
• Identified, document business processes for LIMS and captured As-Is and To-be workflow process diagrams to illustrate exchange data between existing CDS and future LIMS.
• Conducted User Acceptance Testing and documented the UAT summary reports.
• Participated in the design and review of protocols, documents, regulatory submissions and reports.
• Coordinate testing efforts of external systems interacting with core Labware LIMS application
• Worked on Test Rail and Jira for maintaining user stories.
• Involved in Testing Execution and Management activities (Test Design, Reviews & Test Execution, Team Coordination, Regression Testing, Defect Management & Tracking, UAT Support)
• Worked on creating use cases, data modeling, ETL, RUP methodology.
• Work closely with testing team/Dependency systems/Dev Team.
• Worked with QA teams to retrieve test execution and defect reports from ALM.
• Facilitated and documented the scientific content, its usage, business process standards and technical requirements.

Sr Business Analyst

Confidential - Richardson, TX

Responsibilities:

• Created and reviewed business requirements, functional specifications, project schedules and documentation.
• Performed GAP Analysis to check the compatibility of the existing system infrastructure with the newbusinessrequirements.
• Performed requirement gathering & analysis by actively soliciting, analyzing and negotiating customer requirements.
• Analyzedbusinessrequirements and segregated them into Use Case Diagrams, Activity Diagrams, Sequence Diagrams using MS Project.
• Facilitated priority meetings with stakeholders to help business understand the impact of the JIRA in prioritizing them.
• Performed GAP Analysis to check the compatibility of the existing system infrastructure with the newbusinessrequirements.
• Conducted JAD sessions with management, SME, vendors, users and other stakeholders for open and pending issues.
• Accumulated requirements from various departments through surveys and interviews.
• Assisted in the development, design and implementation of new relational or multi-dimensional databases, including the analysis of user needs.
• Created and managed project templates, Use Case project templates, requirement types and traceability relationships in Requisite Pro.
• Completed Unit Testing as well as verification of the XML.
• Involved in the implementation of IT systems, application integration and electronic content management tools such as SharePoint and Documentum.
• Used ISI Toolbox Pharma Edition efficiently for FDA submissions.
• Performed 21 CFR Part 11 GAP Analysis, Risk Analysis, Developed Requirements, Traceability Matrix (RTM) to track requirements for the software application module.
• ValidatedLab WareLIMSto meet 21 CFR Part 11 FDA Regulations.
• Involved in developing and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, CFR Part 210 and GxP GLP, GCP, GMP Compliance Regulations.
• Worked with project manager, SMEs and assisted with the implementation of the Labware LIMS
• Developed business and system requirements, program functions, best practices (GMP, GLP), FDA validation, and 21 CFR Part 11 conditions in a highly regulated environment, for submission of regulatory documents pertaining to drug development.
• Actively involved in creating and updating the templates for the different folders and e CRFs in each application based on phase IV trials from CTMS.
• Developed Systems Specifications document to define the impact of the new requirements on the existing system.
• Involved in Performance Measurement to develop measurable indicators that can be systematically tracked to assess progress made in achieving predetermined goals.
• Developed web and desktop intelligence reports in Business Objects for clinical standards reporting.
• Involved in Training programming staff in query design, automation development and reporting techniques of Business Objects software.
• Implemented solutions that communicated performance metrics, illustrated key trends, and enabled complex business analytics using Tableau, Business Objects, Power BI.
• Coordinated User Acceptance Testing. Creating UAT plans, identified testing scenarios, reviewing test scripts and objectives, provide guidance for system behavior, presenting and reviewing the results with business teams.
• Worked for doing Quality Assurance (QA) to ensure that the letters meet the standards required by the client.
• Coordinated UAT testing by establishing test bed, providing UAT kick off document and supporting UAT testing to make sure the requirements are implemented precisely.

Business Analyst

Confidential - Stamford, CT

Responsibilities:

• Responsibilities:
• Worked with stakeholders, subject matter experts, process owners and users to elicit and document needs, expectations, constraints and external interfaces using various methods.
• Used prototypes for users to explain the intended systems Interface design and sign off documents
• Capturedbusinessrequirements in the form of user stories using JAD sessions, brain storming sessions, focus groups and personal interviews and ensured coverage onbusinessvalues, story points and acceptance criteria.
• Identified inconsistencies and gaps within abusinessprocess description and collaborated with stakeholders to clarify and simplify complex processes.
• Conducted GAP Analysis by documenting the Current state of the business practice AS-IS, analyzed the gaps and provided recommendation for TO-BE.
• Conducted brainstorming sessions with executive sponsors, project champion and stakeholders to document problems with existingCTMSand potential solutions.
• Involved in development of Clinical Trial Management System (CTMS) integrated with EMR and customized to suit protocols following CDISC, GCP and other FDA standards.
• Documented Validation Assessment for the management to understand the importance of validation of core business functionality.
• Worked with project managers and assisted with the implementation of the LIMS software in compliance with the FDA 21 CFR Part 11 requirements, using GAMP guidelines
• Gathered the User Requirements from the Business Users and the Business Sponsor.
• Developed the Functional Specifications based on the Business User Requirements along with the Lead Developer.
• Coordinated with the lead developer to set up and build the prototype of the application.
• Reviewed company wide policies and QA procedures.
• Created a Validation Plan based on the Project Scope, Testing Objectives and Testing Plan.
• Wrote documentation for all aspects of the Computer Systems Validation Lifecycle, in accordance with FDA regulations, particularly Part 11, including: Validation Plan and Protocol, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.
• Created the Test Plan for Protocol Execution and conducted Tester Training for the Test Script Execution.
• Assisted in the set up of the Exception Report Database and coordinated with the Lead Developer to resolve the bugs that was found.
• Reviewed Vendor Audit and Vendor Compliance report for LIMS software
• Executed and reviewed scripts for the formal validation process with implementation of cGMP.
• Maintained the Requirements Traceability Matrix (RTM).
• Drafted new SOPs and trained all users on the systems, implications and impact of 21CFR Part 11 compliant data systems on day-to-day functions.
• Scheduled and documented the formal and informal software design reviews.
• Maintained & tracked the accessibility defects, assigned type using the HP ALM.
• Used SQLs to test various reports and ETL load jobs in development, QA and production.
• Involved in Data Validation and Unit Testing before handing over the data for production and Quality Testing.

Business Analyst

Confidential - Fairfield, NJ

Responsibilities:

• Gathered Business Requirements from the Subject Matter Experts (SMEs) and documented the requirements in the BRD. Utilized data flow diagrams, use case diagrams and process flow diagrams to represent information provided by the Business Owners.
• Conducted JAD sessions and one-on-one meetings with the Stakeholder's and SME's.
• Performed GAP Analysis for new functionality requirements and prioritized them based on thebusinessneeds.
• Assisted in producing and adjusting the Functional Specifications Document (FSD), Data Mapping Documents and the Requirements Traceability Matrix (RTM).
• Developed requirements for the new Pharmacy Benefits Management system (PBM) from the Vendor Drug as-is contracts documentation.
• Documented current workflows and developed future workflows diagrams for PBM vendor.
• Gathered business rules and requirements of different Lines of Business for the PBM process from various key stakeholders of the company.
• Established relativity charts to understand PBMs role and effects on all other functional area.
• Succeeded in implementing a Pharmacy Benefits management (PBM) program using encrypted FTP data feeds.
• Participated in conducting data analysis with the Dataanalystin defining data sources.
• Used Test Director and Mercury Quality Center for updating the status of all the Test Cases & Test Scripts that are executed during testing process.
• Generated monthly reports and graphs using Tableau to identify budget trends and ensure that the unit is meeting the monthly constraints and goals.
• Created process flows, RACI charts, work breakdown instructions, governance policies.
• Created UML Diagrams including Use Case Diagrams, Activity Diagrams, Sequence Diagrams, Collaboration Diagrams, Data Flow Diagrams (DFDs), ER Diagrams and Web Page Mock-Ups using Rational Rose thus defining the Business Process Model and Data Process Model.
• Published functional requirements, screen prototypes on portal for access by all project participants.
• Created screen designs in VISIO for each step of system including all what if scenarios.
• Prepared Status Reports every week, which included Revision History and Test Case Status.
• Ensured the accuracy and consistency of the data during the data loading process.

Business Analyst

Confidential - Chicago, IL

Responsibilities:

• Worked on business requirements by driving user-group meetings and working with various global, cross-functional and virtual teams
• Worked on Agile, and Waterfall SDLC methodologies for project execution, and used Storyboards as one of the requirements elicitation technique.
• Consulted with healthcare third-party Administrator Company to develop conversion specifications for member, enrolment, and authorizations.
• Worked on SQL and other data analysis tools to fulfill plan requested enhancements to existing data products to improve performance of HEDIS measurements
• Involved in Validating system configuration and system enhancements for both Market Prominence MP for project enhancements and standard break-fix items.
• Involved in documenting data sources and transformation rules required to populate and maintain data warehouse content.
• Worked on the UI of the application, prototyping and wire framing in MS Visio for better illustration of the application.
• Responsible for gap analysis in changing old MMIS to new MMIS.
• Worked on requirements management plans, Functional Requirements, supplemental Requirements, Test Plans and Test Cases.
• Involved in requirements Elicitation, Analysis, Communication, and Validation according to Six Sigma Standards.
• Used Use Cases, Activity Diagrams, Sequence Diagrams, OOD using UML.
• Involved in generation and execution of SQL queries.
• Performed Web Page Mock-Ups using MS Visio and thus defining the Business Process Model and Data Process Model.
• Worked on test plan and test criteria for User Acceptance testing (UAT) and System integration testing (SIT).
• Involved in developing the process of Companion Guides for the business users and managed User Acceptance Test (UAT) for business users to explain Mainframe screens for claim processing system.