SUMMARY:

• A highly accomplished skilled and talented IT Professional with 10+ years of experience within the GxP regulated industries.
• As both an individual contributor and team member assisting with strategy, execution and implementation efforts of enterprise solutions.
• Experience with validation, testing and project management and ability to take ownership of projects from beginning to end, with focus on process improvement initiatives.
• Demonstrates broad knowledge of GxP (Pharmaceutical manufacturing, Biotech, Medical Devices Healthcare and Life Sciences).
• Guidance with Quality Management Systems relating to practices involving Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPP), and/or Good Laboratory Practices (GLP).
• Broad and in - depth knowledge and practical experience with System Development Life Cycle (SDLC) & Computer System Validation (CSV)
• Understanding of GxP and Computer Systems / Automation role in support of GxP compliance
• Understanding of GAMP5 and risk-based approach to validation
• Strong communication, technical writing, and analytical skills.
• Hands on experience and best practices for planning and implementing system installation; upgrade; configuration; and related change control and verification activities for Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebook (ELN)
• Self-motivated and direct, with the ability to effectively prioritize and execute tasks in a high-pressure environment
• Ability to understand large complex processes with a focus on continuous improvement.
• Experience with all pertinent industry best practices including development and execution of all applicable system life cycle (SDLC) deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
• Ability to communicate technical concepts to technical and non-technical audiences.
• Extensive knowledge of QMS, including Deviations, CAPAs, Change Controls and implementation of documentation to support Computer Systems operations

TECHNICAL PROFICIENCIES:

Experience in: full system development lifecycle (SDLC), Change Management, Waterfall, Agile/Scrum Methodologies, Understanding of Health Care Systems, Single Payer, Medicaid Managed Care, HIPAA and FISMA Guidelines, Microsoft Office Suite (SharePoint, Word, Project, Visio, PowerPoint, Excel & Access)

Enterprise ERP/MES Solutions: Salesforce SAP/ CRM System Solutions, MS Dynamics

Master Data Management: Microsoft SQL Server 2012

FDA Regulations: Regulated GxP Environments (21CFR Parts 11,21 &,211 and 820), USP 1058

Quality Management Tools: HP Application Lifecycle Management (HP ALM)/Quality Center, JIRA & Wrike

Audit Internal Control Frameworks: CoBIT and COSO, Sarbanes-Oxley (SOX sections 302 & 404)

Electronic Document Management Systems (EDMS): Documentum v 6.x, SharePoint

Incident Management: TrackWise, Maximo, and PVCS Tracker v5.0

Laboratory Information Systems (LIMS): LabVantage, StarLims, LabWare, SampleManager, & Horizon

PROFESSIONAL EXPERIENCE:

Confidential, Raleigh, NC

Sr. Business Analyst (Consultant)

Responsibilities:

• Supported multiple projects to ensure visibility for the business pertaining to Innovation, Renovation, and cost savings.
• Provide guidance and act as a communication conduit between key business users and the IT development team to translate business needs into project requirements documentation.
• Review end-to-end business processes and existing business applications to evaluate how new project requirements impact those processes and ensure integrity throughout the entire process.
• Communicate with business /operational/senior management in order to understand their pain point areas / gaps and identify opportunities
• Coordinate with business stakeholders and SMEs to ensure timely completion of all testing activities as per the project plan.
• Mapping business processes and defining system requirements to support Sales/Services business/operations teams in multiple geographies
• Facilitate test plan/case reviews with cross-functional offshore team members to ensure governance and consistency.
• Coordinate test readiness by ensuring all required test scenarios based on project requirements are represented in test cases, tests are assigned to business team/end-users, users have access, and other requirements to ensure testing can begin successfully
• Provide tactical guidance and coaching in support of systems testing efforts.

Environment: SAP CRM, MS Dynamics, Data Adjudication, Master Data Management, Metadata, User & Functional Requirements, Traceability Matrix, UAT Testing, Defect Tracking, Desktop/mobile platforms, SQL Queries, HP ALM, Agile/Scrum, JIRA.

Confidential, Raleigh, NC

Sr. Business Analyst

Responsibilities:

• Led project meetings and coordinated various technical and managerial teams at all levels including clients, business users and Subject Matter Experts (SME’s).
• Created SDLC documentation to support Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) tools.
• Authored/reviewed system validation documentation, including Validation Plans, Risks Assessments, Qualification Protocols (IQ/OQ/PQ), URS/FRS, Test Scripts, Trace Matrix, and Final Summary Reports.
• Updated and maintained internal templates for SOPs and validation documents.

Environment: EDC, Agile/Scrum, JIRA, Gap Analysis, Master Data Management, Data Integrity, Change Management, User & Functional Requirements, Test Scripts.

Confidential, Deerfield, IL

Sr. Business Analyst

Responsibilities:

• Defined and documented business process flows for Global Laboratory Information System (LIMs) LabVantage implementation / upgrade to v8 from v6
• Coordinated with key stakeholders and IT to gather and document system requirements
• Created user stories, test scripts and reviewed test results within JIRA
• Documented project lessons learned and created/updated PowerPoint slide deck
• Communicated testing status and disseminated information in a timely manner within the team.
• Reviewed Test Summary Reports and routed for approval
• Managed defect tracking and resolution of defects
• Documented and managed Source Documents to LIMS Architects

Environment: GLP, Agile/Scrum, JIRA, Workflow analysis, Master Data Management, Metadata, SQL Queries, Change Control Compliance, LIMS, ELN, Empower CDS, User & Functional Requirements

Confidential, Minneapolis, MN

Sr. Business Analyst

Responsibilities:

• Worked under the guidance of the IT Steering Committee and evaluated current processes and controls across multiple business units. Recommended LabVantage LIMS as a Global solution to address analytics and help reduce the amount of time and errors with the manual entry of assets and inventory management data into the new system to support web, desktop and mobile development.
• Created project plans, updated key timeline phase status changes and tracked financial KPIs.
• Developed current As-Is and desired To-Be Use cases and workflow diagrams to visually represent challenges, risks, and opportunities for process improvements
• Led project meetings with cross functional teams and business sponsors to ensure successful IT delivery for all projects
• Coordinated with off-shore development team on reported defects and verified defect fixes.
• Performed Gap Analysis of existing and proposed system functionality requirements.
• Lead requirements, business process definition and design workshop sessions with internal and external Global teams to identify and enhance business processes, operations, and information process workflows.
• Within an Agile/Scrum environment created requirements & wireframe mockups for healthcare Single Payer system used for management of patient data, billing & reporting. Provided guidance during the completion of the user interface design through the build, test and roll-out phases of assigned projects. Participated and interacted with team regularly for:
• Planning JAD sessions to prioritize and discuss team workload .
• Updated status of assigned tasks for prior/current week and identified any impediments.
• Retrospective meetings to reflect on the previously closed sprint and identify opportunities to improve in the new sprint.

Environment: Sygenta, Community Care of NC, Asset Management, Agile/Scrum, JIRA, Analysis, UI Wireframes, Product Safety, Master Data Management & Adjudication, Metadata SQL Queries, Process Flow Diagrams, LIMS, ELN, Empower CDS, Medicare, Healthcare Single Payer System, desktop/mobile platforms.

Confidential, Durham, NC

Business Analyst

Responsibilities:

• While working under the guidance of the PMO Board, coordinated with various business units and departments (Chemistry, Biology and Chromatography) and assisted in the procurement, selection, design and configuration of proposed Laboratory Information Management System (LIMS) to ensure optimal operational performance.
• Transformed the users’ requirements into functional requirements leveraging both the LIMS/ELN architecture and functionality.
• Created “As-Is” process diagrams to identify bottle-neck areas and potential improvements within business processes against “To-be” workflow process diagrams to illustrate data exchange and ROI of proposed LIMS system.
• Assisted with preparation of project initiation documents and defined requirements necessary for vendor evaluation and selection for potential products/services.
• Developed and incorporated organizational SharePoint workspaces within department to improve productivity and communication.

Environment: Laboratory Information Management System - LIMS, ELN, RFP, Vendor selection, configuration, User requirements, Workflow process diagrams, Enterprise solutions, Change Management, System implementation, Electronic Documentation Management System (EDMS), TrackWise, Chromatography Data Systems (CDS), Empower CDS, Project Server, and USP 1058

Confidential, Evansville, IN

Business Analyst

Responsibilities:

• Lead the remediation, testing and end-user efforts within the Global Data & Reporting department to ensure smooth implementations of new processes and support of Corporate Governance.
• Supported upgrade efforts for customer relationship management (CRM) application used within Call Center.
• Created test scripts and/or performed User Acceptance Testing (UAT) for application enhancements and feature add-ons to support business requirements for proprietary Call Center customer client/web-based application CRIS (Complaint Reaction & Inquiry System) within HP Quality Center (HPQC) infrastructure.
• Supported Medical Affairs Division with ad hoc reporting within application modules for retail customers and management.
• Authored and/or revised Standard Operating Procedures (SOPs) based on change controls generated due to application enhancements and/or annual reviews.
• Documented and assembled PowerPoint material for existing applications supported by Medical Affairs Department.
• Created deliverables, and SDLC (System Development Life Cycle) deliverables, i.e., User Requirements, Design Requirements, Verification Plan and Summary Reports and Traceability Matrix to help drive adherence to regulatory requirements and business needs.
• Extracted product and consumer data and identified common terminology and definitions across interfacing applications to better centralize customer information and optimize responsive customer service.
• Generated pivot tables and reports using Access and SAR (Statistical Analytical Reporting) system.

Environment: Business Analysis, HPQC Script creation, Documentation Tracking and Change Control management, User Acceptance Testing (UAT), Standard Operating Procedures (SOPs), deliverables, SDLC (Software Development Life Cycle) deliverables, User Requirements, Design Requirements, Verification Plan, Summary Reports, Traceability Matrix, Pivot tables, Access and SAR (Statistical Analytical Reporting) system, User Interface Design, CRM, Call Center

Confidential, Washington, DC

Technical-Editor (Consultant)

Responsibilities:

• Assisted in the preparation of Annual Meeting media kits and quarterly presentation materials for non-profit al research organization.
• Edited scholarly content for reports, articles, book chapters, and electronic media for academia research studies.
• Organized institutional research documentation and statistical scholarly data for presentational reports.
• Created mock-ups, workflows and system requirements for both existing and new and interfaces to improve existing user web portal.
• Maintained and updated existing organization’s company-wide intranet and web portal for use by internal staff and external users.

Environment: Documentation Management, Presentation, Statistical information data, User Interface Design, Web Service

Confidential, Piscataway, NJ

Validation Specialist

Responsibilities:

• Actively involved in the remediation and data migration efforts for existing legacy and proposed new ERP system.
• Developed understanding of business requirements while working with business partners, subject matter experts (SME), enterprise architects, and application developers for integration of COTS and Custom applications.
• Created data flow diagrams (current /future state) based on understanding of business needs and application architecture standards.
• Created User Stories and translated workflows based on business user requirements and functional specs.
• Managed medium size project team and facilitated JAD sessions to updated project team tasks.

Environment: Requirement Gathering, Change Control, Data flow diagrams, MS Visio, User Stories, Workflows, Business user requirements and functional specifications, SDLC, ERP and JAD (Joint Application Development) sessions

Confidential, Rockville, MD

Senior Validation Engineer (Consultant)

Responsibilities:

• Developed requirements for new systems and enhancements to existing systems.
• Authored master validation plans, testing protocols (IQ, OQ and PQ) and reports using computer systems qualification/validation documentation standards and maintained deliverables in electronic document management system (EDMS).
• Performed user acceptance testing to emulate the intended audience of various applications to assure understanding of the application and its features and functions.
• Managed change requests, traceability matrix to include acceptance, installation, and deployment of solutions.
• Performed systems integration and regression testing in agile test environment and validated changes.
• Documented and tested GUI dashboard interface for electronic medical /healthcare web-based CRM application used to support clinical and medical salesforce automation staff
• Provided peer reviews for validation deliverables developed and executed by core team members.

Environment: Electronic document management system (EDMS), Change Control Management, Validation & Testing, Agile, Electronic medical /healthcare web-based CRM application, TrackWise, Documentum, Salesforce