CERTIFIED TrackWise Configuration Analyst * RAS / BOE Enterprise
CERTIFIED TrackWise Validation Analyst *Sparta Systems Validation Pack
Multifaceted Quality Systems technical career record of innovation and success

Highly skilled senior technology professional with solid experience in TrackWise Administration Complaints, decision tree, Adverse Events, CAPA, LABWARE 6 Change Control, Deviations, and custom Trackwise workflow Development. Full lifecycle application design, methodology and data modeling (Oracle), with strong facilitation skills to capture business requirements and prepare for coding. Analyze and translate user requirements into use case documentation for technical architects.LabWare, Documentum, Livelink, and Sharepoint validation skills with 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 within budget. Effectively manage scope and objectives. Utilize excellent interpersonal and communication skills; experienced in remaining highly focused within 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 with External Fields. Hands on Trackwise 6.0 and 7.0 upgrades 7.0 SR-5. Use Issues Log to control and mitigate risk for assigned issues to meet controlled floating dates and Trackwise business rules.
Core Competencies:

• TrackWise 6.0 & 7.0
• Tw 6 to 7 upgrade SR-5
• LabWare 6
• Import Selection Utility
• Crystal Reports 11, and XI RAS
• Documentum / Livelink Validations
• GXP / EDMS VALIDATION
• Trackwise Coordinator 6.0 / 7.0
• TrackWise Admin / Queries
• JAX-WS, AXIS2 Web Service
• Trackwise 6 / 7 OQ / PQ
• Custom Admin Triggers

Professional Experience

Senior TrackWise Business Analyst - Confidential, August 2003 - Present
Contracts: Confidential
Lead TrackWise development for materials and raw materials tracking for QA and QC release, and participated on TrackWise and validation teams for this pharmaceutical / biotech consulting firm.

• Lead implementation, configuration and support of TrackWise® 7.0, Crystal Reports 11 RAS and tracking software at customer sites, including analysis and documentation of customer requirements, installing TrackWise software, configuring to implement customer requirements, assisting with validation and training TrackWise administrator / users. Compose admin queries, scopes and schedules, and configure admin activities and triggers for TrackWise Coordinator. Customized over 218 OQ scripts for Calibration Preventive Maintenance for Abbott Labs. Re-engineered over 200 OQ COTS scripts from the Sparta Systems IQ, OQ Validation package using 7.0 SR-5.

Key Achievements / Projects:

• Configured Trackwise Project - LabWare Integration analysis and lot calculations for the Non Conforming Materials / Lot Ship Hold Freeze / SAP Web Services Integration: - Web.XML custom configuration.
• Configured Trackwise Project - Non Conforming Materials / Lot Ship Hold Freeze / SAP Web Services Integration: - Web.XML custom configuration,
• Custom NCM Project CAPA / Action Items / Deviations
• 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 with Internal Checklist) configured with all Audits - Internal, External, and Supplier Audits.
• 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
• Developed new Calibration Preventive Maintenance System CAL/PM in Trackwise as a new Project.
• Configured a new admin module in the current system based on the user requirements:
  Lead developer with the design of system configuration, including States, Activities, Workflow, Group Categories, Data Fields, Required Fields, PR Tasks, Terminology, Notifications, Projects, Project Membership and Login Accounts. Used Microsoft .Net to customize Trackwise Splash screens and pop-up on-line help for fields and navigation. (Supported Apache Tom Cat Web Services) which replaced IIS for TW 7.0 upgrade.
  
• Acted as in house Trackwise admin / support with daily design updates to the TrackWise Coordinator configuration, including Admin Queries, Admin Schedules and Admin Activities; Customized report templates, created new report templates.* Upgraded 9 Reports to new Crystal Ras XI Reports.
• Built a custom TW 7.0 CAPA system, track operational information, such as training, changes / change control, deviations, failure investigations, audits to facilitate efficient audit and retrieval of information, and to aid in trend analysis.
• Assisted in investigation and evaluation of deviations, failures and trending. Develop Crystal Report templates for TrackWise reports, and forms for material approval and evaluations, change control, and workflows. Worked with process owner / project manager to evaluate and develop logical workflows, supporting single and parallel workflows, states, activities, group categories and folder permissions. Responsible for SAP export and import file picked up by Import Selection Utility (configured as a service). Develop test plans and protocols, including IQ, OQ, PQ, and DQ, audits / incidents and prototype config forms.
• Served as Lead Validation Analyst, collaborating with process owner / project manager to evaluate and develop validation test scripts. Install and configure development and validation instances. Develop validation protocols such as IQ, OQ, PQ, DQ, Summary Reports and support Validation 5.9 to 6.0 upgrade, including TrackWise 6.0 training documentation.

Key Achievements / Projects:

• 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 with all clients, including Abbott and Bayer.
• Re-installed team access module and Crystal Reports XI, turning all documentation into Medicis, on time and within 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 with user groups linking to specific settings for admin required classes.

Confidential, Triangle Park, NC 1996 - 2003
Lotus Notes / Trackwise Business Analyst

• Trackwise admin 4.8 - 5.9 Bayer Full-Time Employee
• Developed and maintained Lotus Notes databases, Domino Web applications, and reporting utilities in support of Discrepancy Event Reporting (DER) for development of biological products used to fight life-threatening diseases.

Installed, configured, and validated TrackWise, including 13 projects and 26 test cases; tested and implemented configuration changes for TrackWise 5.9 and Team Web Access 4.9. Served as subject matter expert on computer validation and QA at multiple sites. Managed and supported database technologies, including desktop support. Supported Vendor Audits and Laboratory Information Management System (LIMS).
Configured TrackWise to track actions and disposition extensions, production releases, and incidents. Developed and deployed system monitoring Discrepancy Event Reporting (DER) and Corrective Action / Preventative Action (CAPA), preventing lots from reaching production without approval from compliance, regulatory, and QA discrepancy management. Wrote test scripts and collaborated on testing for Electronic Document Management System (EDMS) Documentum 5.0 with Oracle 9I backend. Designed and implemented testing / validation for regulatory and corporate compliance notification database in Lotus Notes and ASP, enabling FDA communication and corrective action review.

Key Achievements / Projects:

• 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 within 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 within budget for all 13 validated applications, including gap analyses with summaries.
• Received 13 awards 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,Triangle Park, NC 1993 - 1996
Lotus Notes Web Developer / Software Developer II

• Collaborated on six-person development team designing and developing new, automated Requirements Management System, a multi-database Lotus Notes application.

Developed and maintained multiple Lotus Notes databases supporting of major business processes, including materials tracking, process tracking, and project management and workflow. Implemented / supported business requirements through design and implementation, testing, troubleshooting, and maintenance. Converted data from PL/I, SQL-DS mainframe environment to Lotus Notes, OS/2 environment.

Key Achievements:

• 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 knowledge by learning True Workflow and Validation CFR 21 part 11, laws regarding electronic signatures and utilizing Oracle database in a true client-server environment.

Education and Credentials

Bachelor of Science Degree, Major in Computer Science

Certification
TrackWise 5.8/6.0/7.0
Professional Development

Technical Proficiencies

Platforms:

Microsoft Windows 2003/NT/2000

Software:

.Net Livelink 9.5, Documentum 5.1 EDMS Integration with Trackwise 4.8, 5.8/5.9, 6.0, 7.0, Lotus Notes 6.0 / R-6 CLP, Lotus Script, Lotus LSXsWeb Domino, Same-time, Discovery, Workflow 3, Whiteboard, PDA, Notes Pump, Get Access, SQL/PL, Development 2000, Crystal Reports

Database:

Oracle 10G, SQL Server, Labware LIMS EM Module and Inventory Control.

Languages:

Visual Basic, Visual C, C, Oracle PL/SQL, SQL Query, JavaScript, Java, Corba, ASP I/II

Computer Skills: Outlook, Access, Certified TrackWise 6.0 and Trackwise 7.0 SR-5, LMS, EDMS, Visio, Microsoft Project, and Excel.