SUMMARY

• 7 Years of IT experience as a Sr. Business Analyst / Quality Analyst in SDLC: analysis, design, development, deployment, testing, and implementation of projects for various business and finance organizations.
• Excellent skills in Business Analysis, Data Analysis, GAP Analysis, Financial Data Analysis, Risk Analysis, Requirement Analysis, Business Modeling and Use Case Development using UML methodology.
• Experience in developing business and functional Requirements, including requirements traceability, categorization, and prioritization
• Proficient in using UML for Business Process Modeling, Use Cases, Activity Diagrams, Sequence Diagrams, Data Flow Diagrams, Collaboration Diagrams, Class Diagrams and document them using MS Visio.
• Worked on different SDLC Methodologies including Waterfall, Agile & RUP.
• Strong experience writing Use cases, Business processes, work flows and process flows using Microsoft Visio.
• Extensive Product Lifecycle Management knowledge. Proficient in Siemens PLM Tool - TeamCenter Unified (TcU) knowledge
• Excellent analytical skills for understanding and gathering requirements, business rules/processes and detailed design of the application including generating use case models, analyzing diagrams and Data Flow Diagrams.
• Practical knowledge of API design with a focus on scalability, consume-ability, and flexibility
• Experienced working with Excel Pivot and VBA macros for various business scenarios
• Possess solid understanding of Software Development Methodologies, Business Process Modeling, and Business Analysis.
• Interact and coordinate with end-users, vendors, development and QA team, suggesting key enhancements and changes to the business architecture.
• Strong understanding of GxP quality guidelines: Good Manufacturing Practice, Good Laboratory Practice (GLP), Good clinical Practice (GCP), Good Distribution Practice (GDP), and Good Regulatory Practice (GRP).
• Experience in technical writing of validation protocols Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Standard Operating Procedures (SOP) per 21 CFR Part 11 and FDA regulations
• Conduct and participate in User Acceptance Testing (UAT)
• Knowledge in using AGILE/Scrum methodologies, following Scrum Master, sprint/standup sessions and created storyboards, analyzed the Iteration Burn Down charts and reviewed defects.
• Conduct JAR sessions and interact with internal and external Stakeholders to resolve issues.
• Create and transform business requirements into software requirement specification (SRS) and design business models using use case model, analysis model, activity diagrams, and sequence diagrams in MS Visio.
• Analytical, methodical and resourceful approach to Problem Solving, Root-Cause Analysis, Conflict Resolution, Negotiation Strategies and providing corrective actions to meet business requirements.
• Trained/Coach new hires on Change Management System.
• Possess excellent coordination, negotiation and interpersonal skills.
• Excellent communication skills used to facilitate requirements and communication between the client and the project team.
• Conduct internal training programs for various applications. Update, and review training documentation and course materials.
• Good understanding of Defect and Change management process using HP Quality Center/ALM.
• Experience with Remedy, ISOtrain, PLM systems

TECHNICAL SKILLS

Methodologies: Unified Modeling Language (UML), AGILE/Scrum, Waterfall SDLC, RUP, FDA 21 CFR 820 & 211

Requirements and Document Tools: Rational Requisite-Pro, Rational ClearQuest

Business Modeling Tools: Rational Rose, Rational Requisite Pro, Microsoft Visio. Lucidchart, Vuetify

Project Management: Microsoft Project, Microsoft Office (Word, Excel, PowerPoint, Access, Smartsheet, OneNote, SharePoint, Teams), ServiceNow, OKTA

Databases: SQL Server, Microsoft Access, WebFocus, Oracle

Operating Systems: Unix, Linux, Microsoft Windows, Mac OS

Testing Tools: Win-Runner, Load-Runner, Quick Test Pro, JIRA, Confluence, HP ALM

Survey Tools: Microsoft Forms, Survey Monkey

PLM Tools: Siemens TeamCenter Unified

PROFESSIONAL EXPERIENCE

Confidential

Project Manager/ Senior Business Analyst

Responsibilities:

• Lead Front End team using analytical skills for understanding and gathering requirements, business rules/processes and detailed design of the application including generating use case models, analyzing diagrams and Data Flow Diagrams.
• Lead and conduct JAR sessions and one on one interviews to interact with internal and external Stakeholders to prioritize project requirements
• Provide analytical, methodical and resourceful approach to Problem Solving, Root-Cause Analysis, Conflict Resolution, Negotiation Strategies and providing corrective actions to meet business requirements.
• Facilitate sprint planning, daily scrums, retrospectives, stakeholder meetings, and software demonstrations.
• Protect development team from outside distractions, impediments, or team conflicts, and maintain focus on product backlog project timeline.
• Work closely with project owner in backlog management and continuous delivery of features and analyze the Iteration Burn Down charts and reviewe defects.
• Educate and reinforce scrum methodology and agile framework to team members and stakeholders
• Performed change / Incident ticket management using ServiceNow.
• Monitored the project processes, making periodic changes, authoring progress and completing reports which were then submitted to the Project Management Office (PMO) on a weekly basis
• Develop a business architecture strategy for the business unit based on a situational awareness of various business scenarios and motivations.
• Apply a structured business architecture approach and methodology for capturing the key views of the business unit in the context of the enterprise.
• Capture the tactical and strategic business goals that provide traceability through the organization and are mapped to metrics that provide ongoing governance.
• Describe the primary business functions of the assigned business unit in the context of the enterprise and distinguish between customer-facing, supplier-related, business execution and business management functions.
• Conduct weekly meetings for deciding the Policies and Procedures to be followed while constructing new sites.
• Interact with Junior Business analysts, QA testers, and Developers to collect their work status and kept the Project Schedule up to date
• Define the data elements shared between this business unit and other units in the enterprise and the relationships between those data elements and processes, people, systems, and other data elements.
• Enumerate, analyze, and suggest improvements to the structural relationships of the business. This requires the creation and maintenance of an ongoing model of roles, capabilities and business units, the decomposition of those business units into subunits, and the interplay between these units in various business processes, materials, people, and systems.
• Extensively work on BRDs (Business Requirement Documents) and supported documents containing the essential business elements, detailed definitions to analyze and document business data requirements.
• Write requirement documentation using Gherkin form and build process workflows that aid in understanding of requirements
• Documented the Business requirements based on HIPAA compliance rules
• Create and conduct Front End design review session for the mock-up wireframes to translate into prototypes
• Participate in requirements prioritization through excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts
• Provide demos and training of new functionality to internal teams with an ability to read, analyze, and interpret documents and technical procedures
• Create UML for Business Process Modeling, Use Cases, Activity Diagrams, Sequence Diagrams, Data Flow Diagrams, Collaboration Diagrams, Class Diagrams and document them using process modeling tools
• Work on analyzing and developing various system integration plan
• Strong experience writing Use cases, Business processes, workflows and process flows
• Analyze, develop and implement an audit response communication plan that accounts for internal stakeholder and Auditors of AXA
• Work on providing metrics and process improvement recommendations on KPMG’s audit response and remediation processes and implementing approved recommendations
• Work with Project management team to Develop and implement an ERM strategy to identify risks and applicable mitigation controls
• Perform procedures to validate the implementation of agreed remedial action points reported to the senior management

Confidential

Business Analyst/ Data Analyst/ Quality Analyst

Responsibilities:

• Drafted, documented and conducted team review of Application Change Controls per the Change Requests and vendor provided patches
• Owned and managed updates to Change Controls
• Worked on creating Operational Qualification (OQ) and Performance Qualification (PQ) test cases
• Wrote and reviewed detailed Test Cases in ALM with in-depth description of each test scenario.
• Involved in approving test case in ALM along with Quality representatives
• Documented and worked on detailed Trace Matrix for project
• Updated and maintained project document information in the Document Management System, assured uniformity that documentation is processed consistently in a periodic manner
• Scheduled weekly status meetings to communicated issues, solutions and concerns.
• Prioritized IT enhancement requests and backlogs tasks with Scrum Master.
• Worked closely with SMEs, Business departments, IT Analysts and Project Managers to analyze the core requirements and key features of the ongoing project.
• Successfully used AGILE/Scrum Method for gathering requirements and facilitated user stories workshop. Documented User Stories and facilitated Story Point discussions to analyze the level of effort on project specifications
• Acted as a lead in Global Deployment process of various Regions (LATAM, APAC, EMEA, UCAN etc.) to support onboarding of 8000 users into TeamCenter Unified.
• Responsible for translating PD business requirements into a solution, with Teamcenter as the PLM
• Worked with global users on application Workflows and reports for Medical Devices, Products and Documents
• End of the year TeamCenter Annual Account review of 8000 Active users alongside Human Resource Team
• Used guidelines and artifacts of AGILE software development methodology to strategize the implementation in different iterations and phases of the Software Development Life Cycle.
• Worked on creating User Manual, Job Aids and other training material for end users
• Involved in project as a primary QA in developing and writing test plans, scripts, execute tests and reporting results.
• Drafting of Training Material, Standard Operation Procedure (SOP), Global guidance documents and Job Aids
• Involved in writing Validation Plan, Summary Reports and Detailed Risk Assessments
• Developed test plan, Test cases and test scenarios to be used in testing based on business requirements and technical specifications.
• Involved in creating Performance Qualification (PQ) test scripts and determining testing methodology
• Document and track defect after each test cycle and determine the defect resolution and closure
• Open IR’s, PR’s and ER’s with vendor based on defects
• Worked on Validation cycle of IQ, OQ and PQ’s
• Involved and coordinated various testing activities such as System Integration Testing (SIT), Regression Testing, Sanity Check Testing
• Facilitate the Scrum calls with Product backlog owner and other team member to do Sprint planning, Sprint retrospective
• Developed AGILE User Stories,Epics, Features by providing well defined story descriptions and Acceptance Criteria.
• Conducted weekly Technical review board (TRB) meeting to discuss new enhancement request with Stakeholder and technical team and lead the prioritization effort.
• Work closely with TcU ARO (Help desk) team in resolving tickets raised by end users
• Implement the whole Life cycle of UAT methodology starting from Planning, Capturing, creating, Executing, Reporting, and tracking the defect using JIRA and HP Application Lifecycle Management
• Established and maintained relationships with vendors and stakeholders
• Involved in Proof of Concept (POC’s) with team
• Act as customer service expert in identifying and troubleshooting issue to provide solution to end users
• Extensively worked on BRDs (Business Requirement Documents) and supported documents containing the essential business elements, detailed definitions to analyze and document business data requirements.

Confidential

Business Analyst

Responsibilities:

• Worked on the various phases of SDLC.
• Worked with the business team and technology team in substantiating the Business and System Requirement Specification document for the project.
• Served as a liaison between the business and technical team.
• Analyze requirements utilizing various methods. (E.g. sample data from SQL queries, Screen Shots, reports, prototype screens, sourcing information and other data models)
• Performed project management activities such as task scheduling, resource allocation and developing charts.
• Designed detailed logical class diagrams, activity diagrams and other high level process flows.
• Facilitated JAD (Joint Application Development) sessions with the management team, stakeholders, FC's and mainframe team.
• Performed high level security data risk analysis, GAP Analysis among different applications, incorporated these gaps into models and documents
• Work with interfacing applications to identify changes to the systems and communicate impact of the change to development and support teams.
• Maintain Interface documentation and agreements.
• Used SQL queries to filter data within the Oracle database
• Coordinate test environments and test data availability between the systems.
• Follow up with requirements, data modelling and testing teams for the SDLC process.
• Provide weekly status reports and ensure completion of tasks assigned.
• Responsible for continued system improvements to help reduce development costs.
• Perform custom, ad-hoc data analysis and reporting based on stakeholder requests
• Involved in Data mapping specifications to create and execute detailed system test plans. The data mapping specifies what data will be extracted from an internal data warehouse, transformed and sent to an external entity.
• Analysis of functional and non-functional categorized data elements for data profiling and mapping from source to target data environment. Developed working documents to support findings and assign specific tasks