SUMMARY:

• To take a challenging role on business operations as Business Analyst and give an efficient and effective solution that would help the organization to achieve the best solution in business which would increase its productivity in market.
• 3+ years of experience as a Business Analyst in both pharma and mortgage sector.
• Excellent communication skills, writing skills as well as presentation skills.
• Experience working with business users as well as senior management.
• Advanced knowledge of Software Development Life Cycle (SDLC) operations using methodologies like AGILE - SCRUM and Waterfall.
• Expertise in Requirements Gathering, Functional and Technical Requirements Specifications, Scrum meetings, JAD sessions, User Acceptance Testing and Traceability Matrix.
• Knowledge and experience in working with GxP (cGMP, GDP, GCP, GLP) suites and SOPs.
• Strong knowledge about pharmaceutical/medical device regulations like FDA, 21 CFR Part 11, Part 210, Part 211, Part 820.
• Application of SDLC with thorough understanding of various phases such as Requirements Analysis, Design, Development, Testing and Implementation.
• Extensive experience with Business Use Cases, Functional Use Cases, Business Process Models, Test Cases for standard, specialized and SOA (Service Oriented Architecture) requirements.
• Strong knowledge of UML, Rational Suite including Rational Rose Requisite Pro, Clear Quest
• Adapt in documentations such as, BRD, FSD, Use cases, User stories, Test cases and UML diagrams.
• Excellence working with Stakeholders including Clients/Owners, SMEs, developers, testers, users and customers.
• Excellent communication and involvement skills participating in Scrums with cross-functional teams.
• Good experience in Analyses, including GAP analysis (as-is and to-be processes) and SWOT analysis.

TECHNICAL SKILLS:

Software Development Methodologies: Agile - Scrum, Waterfall

Requirements Management Tools: Blueprint, Quality Center, Axure, JIRA

Process Management Tools: MS SharePoint, Google Docs, Documentum

Requirements Visual Modeling Tools: Rational Rose, MS Visio

Testing Tools: Quality Center, Quick Test Pro (QTP)

Industry Standards and Compliance: FDA, 21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, cGCP, cGLP, cGDP), GAMP 4, VMP Validation Protocols (IQ, OQ, PQ), SOPs, LIMS, CDISC, HHS, OSHA

Languages: SQL, HTML, XML

Microsoft Technologies: MS Word, MS Outlook, MS PowerPoint, MS Excel, MS Project

Hardware and Platforms: Windows 7/8/10

PROFESSIONAL EXPERIENCE:

Confidential, Frederick, MD

Business System Consultant

Responsibilities:

• Gathered the Business Requirements (BRD) and developed Functional Specification Document and the Requirements Traceability Matrix (RTM) by coordinating with the multiple Business teams and the Technology groups.
• Involved in the creating the User Interface Specification Document and User Training Manual as per project specification with the help of development team.
• Performed User Acceptance Testing (UAT).
• Conducted highly interactive JAD sessions with project’s stakeholders such as users, QA analysts, and project management team, identifying and resolving issues.
• Utilize MS Visio for gathering and communicating requirements.
• Actively participated in focus groups in gathering smart ideas to improve the system and bring unique experience to the end users.
• Analyzed the requirements and designed prototypes and worked on preliminary user manuals.
• Identified and analyzed the core business ideas and methodologies to define and document business processes and prepared project progress reports.
• Collaborated with business members, BI Team members and technical SME’s.
• Conducted workflow, data analysis and GAP analysis to derive requirements for existing systems enhancements.
• Responsible for design, development and completion of project deliverables such as business requirements, Use Cases and test scripts plus End User Support (SharePoint, Project Management, UAT).
• Designed Use Cases, Use Case Diagrams, Use Case Scenarios, Workflow and Data Flow Diagrams. Business Process Flow Diagrams, Activity and Sequence Diagrams using Microsoft Visio.

Environment: Waterfall, JIRA, Confluence, Windows XP, Blueprint, MS project, MS Word, MS Visio, MS excel, MS project, Windows 10

Confidential, Bethlehem, PA

Business Analyst

Responsibilities:

• Incorporated the best practice methodologies to develop a structured approach during the overall Software Development Lifecycle (SDLC).
• Involved in the Inception phase of the SDLC process in gathering and documenting of the requirements.
• Ensured the required modifications and specifications were incorporated into the application.
• Prepared monthly project status reports describing the status quo to date, impact of issues and changes in requirements necessary.
• Conducted walkthrough sessions with the Subject Matter Experts (SME's) and finalized the functional design of the system based on discussions and comments.
• Ensured the documentation is in compliance with GxP's.
• Validated Login screens and access profiles in FrameworksTLC based on the user requirements for User Interface (UI) testing.
• Assisted in generating the Error Report Form and resolving the errors encountered during the testing effort and maintained the Error logs for the errors.

Environment: Waterfall, JIRA, Windows XP, Frameworks, MS project, MS Word, MS Visio, MS excel, MS project

Confidential

Business Analyst

Responsibilities:

• Gathered business requirements through interviews, questionnaires, prototyping and observations of operational management team and analyzed and prioritized user and business requirements.
• Writing and storing BRD’s in compliance with FDA rules and regulations.
• Conducted JAD sessions to allow different stakeholders to communicate their perspectives with each other, resolve any issues and come to an agreement quickly.
• Analyzed various aspects of the current state of the business process undergoing change and developed a framework for strategic planning using SWOT Analysis and Gap Analysis.
• Prepared system requirement specification based on product requirement.
• Designed and developed Use Cases, Activity Diagrams and Sequence Diagrams using UML and MS Visio.
• Supported the assigned project manager with creating detailed project plans assisting in developing, scheduling and tracking project timelines.
• Worked with the project managers and assisted with the implementation of software in compliance with the FDA and 21 CFR Part 11requirements using GAMP guideline’s.
• Preparations of Validation Summary Report (VSR’s) and Standard Operating Procedures (SOP’s).
• Assisted in generation of validation plan
• Creation of Auditing IQ’s, OQ’s and PQ’s for all processes for compliance.
• Arranging meetings to discuss report progress and discuss non-compliance issues and how to deal with them.
• Adopted Agile/ Scrum through daily stand-ups, sprint retrospectives, group estimation techniques and customer sprint demos.
• Reviewing gap analysis reports, remediation plans and corrective and preventive action (CAPA) reports to track deviation handling.
• Prepared Business Requirement Document(BRD) and helped system analysts to prepare Functional Requirement Specifications (FRS) and User Requirement Specifications (URS).
• Reviewed documents with the designers, developers and stakeholders.
• Utilized reporting tools for project tracking, supporting the development team through every stage of the analysis process.

Environment: Agile- Scrum, UML, MS Visio, JIRA, MS Word, MS PowerPoint, MS Excel, Windows 8