SUMMARY

• Highly skilled as a senior technology professional wif solid experience as a Certified TrackWise Analyst wif Strong Administration, Validation and Development skills. L2, L3 Support
• Worked wif Sparta Development Services and 3rd level support for all escalated issues. STRONG INSTALLTION OF TRACKWSIE ON 5+ SERVERS IN CLUSTER WITH LOAD BALANCER. UNDERSTANDS IQ AND SERVIC SETUP FOR WEB SERVICES AND TRACKWISE COORDINATOR SERVICES. CAN CUSTOM INSTALL MULTIPLE INSTANCES TO ACCOMADE TWC RUN - TIME INTERVALS
• Full lifecycle application design, methodology and data modeling (Oracle + SQL SERVER connections), wif strong facilitation skills to capture business requirements and prepare for coding. Analyze and translate user requirements into use case documentation for technical architects. Proven success in driving data center projects and enterprise-level IT implementations and projects while leading teams, scheduling project tasks, and ensuring that installed solutions are deployed on time and wifin budget. TEMPEffectively manage scope and objectives.
• Utilize excellent interpersonal and communication skills; experienced in remaining highly focused wifin fast-paced, demanding environments. The following systems have been custom development: Calibration / Preventive Maintenance, CAPA, Discrepancy Event Reporting - Raw Materials & Materials, EH&S, and SAP integration wif External Fields.
• Hands on Trackwise 6.0 and 7.0 upgrades Installation of IWS and OWS for Web Services. Use Issues Log to control and mitigate risk for assigned issues to meet controlled floating dates and Trackwise business rules. Support Level Tickets for Go Live Daily.

PROFESSIONAL EXPERIENCE

Senior Trackwise Developer

Confidential

Responsibilities:

• Developed/Supported Web Services Outbound / Inbound wif Sparta guidance from Trackwise to SAP - Copy Complaint PARENT Value down to Child ITR. SAP/PI to Trackwise - IWS search / update and Create PR record in Trackwise.
• Delivered P1, P2, and P3 ProtoType Evaluations to the Business
• Developed USE CASES - Lead Business Requirement meetings
• Lead the Trackwise Teams and supported the Project Plan - Project Manager activities
• Developed over 80 use cases converted to Test Scripts for Validation activities.
• Built custom Event & Complaint, Action Items, Tasks, Reconciliation, Notice of Event, Investigation and CAPA reports. Including early warning, trend, Interim report, and custom Full Detail Reports. Crystal Ras XI.
• TrackWise 7.x and 8.x Configuration and Validation
• Re-Configuration/development/validation for Supplier Audits, Internal/External Audits, SCAR
• Creation of Risk Assessment and Mitigation workflow.
• Creation of Patient Safety workflow
• Creation/Update of SDLC documents.
• Configuration/Validation Execution of TrackWise 8.3.2 to 8.3.5 upgrade.
• Creation of external connection systems to perform actions outside of TrackWise
• Supported Reports for QA. Developed over 50 reports from 60+ templates for optimization performance and updated fields. Used both Running Totals and TW V for the views.
• Advanced Levels: Developed new workflows, TWC services: Advanced Admin Querys, Single and Multiple reports: Custom Dashboards: Custom Audit Trail History Reports.
• Helped write OQ and PQ test scripts

Senior Trackwise Analyst

Confidential

Responsibilities:

• Developed Web Service Outbound from Trackwise to Documentum
• Setup Documentum and Trackwise for Document Management System EDMS
• Web Services Outbound
• Upgraded Training material / Trained users daily/ weekly / and twice a week until all local users trained.
• Cognos Studio Report Development / Support for Investigations, Action Items, and CAPA.
• Supported Reports for QA. Developed over 50 reports from 60+ templates for optimization performance and updated fields.
• Developed new workflows, TWC services: Querys, Single and Multiple reports: Custom Dashboards: Custom Audit Trail History Reports
• Day to Day Trackwise Configuration attend meetings and implement requirements.

Senior TrackWise Business Analyst

Confidential

Responsibilities:

• Configured TrackWise Audits for Corporate Compliance Services and EHS. Installed TrackWise 7.0 Development Instance and TrackWise 6.0 Validation Instance. (Setup Migrator and Audit Manager wif Internal Checklist) configured wif all Audits - Internal, External, and Supplier Audits.
• Supported enhancements daily wif approved change control request for both Quality and IT.
• Used migrator tool to migrate controlled changes from Test/QA, Production.
• Trackwise 7.0 Updated over 200 OQ/PQ Scripts
• Trackwise 7.0 Updated 2 Installations for both GSQ Audit and QTS Audits.
• Trackwie 7.0 Updated Installation Scripts for Oracle XML and TomCat

Developer

Confidential

Responsibilities:

• Configured TrackWise Audits for EHS and installed TrackWise 6.0 Development Instance and TrackWise 6.0 Validation Instance.
• Collaborated on the writing of 132 test scripts, and wrote Installation Qualification instruction for production instance for Global Manufacturing Flu-Vaccines, supported QA, QC release and change control.
• Installed, configured and wrote requirements and config specification documents for TrackWise 6.0 and Team Web Access 6.0, and participate on validation team.
• Recognized for consistently excellent customer service and retention wif all clients, including Abbott and Bayer.
• Re-installed team access module and Crystal Reports XI, turning all documentation into Medicis, on time and wifin budget.
• Installed development, validation and production environments and Crystal Reports 9.0 and XI, keeping management updated and supporting team collaboration.
• Served as Lead Support Product Specialist for supplier audits; setup user account and configured group categories, including customizing roles wif user groups linking to specific settings for admin required classes.

Confidential, Research Triangle Park, NC

Lotus Notes / Trackwise Business Analyst

Responsibilities:

• Developed Crystal Report templates for TrackWise and single / multiple reports for Adverse Avents.
• Served as Project Manager for Regulatory Affairs Notification Lotus Notes Database, identifying business requirements, defining system scope and schedules, managing costs, and supervising four contractors; project successfully delivered wifin schedule and cost constraints.
• Executed and wrote test scripts and validations, tracing ability matrix for TrackWise 4.9 and change control, audit manager, G-23 Material Tracker / Raw Materials Tracker, SOPs Tracker and training materials.
• Completed patch upgrade 5.9 on time and wifin budget for all 13 validated applications, including gap analyses wif summaries.
• Received 1 award for quality work and service, a Special Recognition Award from Customer Service and a Certificate from Senior Vice President of Quality for successfully completing DER system.

Confidential, NC1

Lotus Notes Web Developer / Software Developer II

Responsibilities:

• Successfully designed complex forms, views, and databases, implementing access and security control.
• Redesigned and refined Action Tracker database and developed administrative systems using Lotus Notes.
• Saved IBM $2.2M by convincing management to utilize new software technology to satisfy evolving requirements; utilized Notes Pump to provide back-end query capability, avoiding integration of system 390 and clustered Domino server.
• Dramatically expanded noledge by learning True Workflow and Validation CFR 21 part 11, laws regarding electronic signatures and utilizing Oracle database in a true client-server environment.

TECHNICAL SKILLS

Platforms: Microsoft Windows 2003/NT/2000

Software: .Net Livelink 9.5, Documentum 5.1 EDMS Integration wif Trackwise 4.8, 5.8/5.9, 6.0, 7.0,8.45 Lotus Notes 6.0 / R-6 CLP, Reliance foundation built on Lotus Script 3.1, Lotus LSXsWeb Domino 5 and 6, Same-time, Discovery, Workflow 3, Whiteboard, PDA, Notes Pump, Get Access, SQL/PL, Development 2000, Crystal Reports XI Some Universe Development limited:

Database: Oracle 10G, SQL Server, Labware LIMS

Languages: Visual Basic, Visual C, C, Oracle PL/SQL, SQL Query, JavaScript, Java, Reliance JSP Support for ETQ Corba, ASP me/II

Computer Skills: Sparta Systems Trackwise 8.5. Reliance Software: Certified ETQ 6.2, 8.0, and 10 Outlook, Access, Certified TrackWise 6.0 and Trackwise 7.0, Trackwise 8.45, SR-5, LMS, EDMS, Visio, Microsoft Project, and Excel.