SUMMARY:

• Experience in the configuration/upgrade/validation of TrackWise 7.x and 8.3.5
• Experience interfacing and building relationships with all stakeholders to analyze, design, and configure TrackWise to provide a solution to a business need. This includes creating and maintaining all supporting system validation documentation (per SDLC) and assisting the stakeholders with their responsibilities such as User Requirements and SOP’s as required and requested.
• Experience with creating, maintaining and testing Crystal Reports.
• Experience tracking deliverables to meet deadlines using several tools.
• Proven decision and troubleshooting skills keeping systems up under production pressures and constraints.
• Experience monitoring and maintaining all aspects of TrackWise with in a cGXP environment utilizing change control procedures.
• Experience working with Confidential regarding on site audits.
• Worked with TrackWise systems for more than 10 years, starting with one of the first versions of the software.
• Creative, customer focused, results - driven, cGXP Computer Systems Validation Specialist with a broad level of experience with TrackWise™ System Design/Integration/Validation, Administration, and Troubleshooting.
• Wide variety of Computer Systems Validation experience including the Systems Development Life Cycle (SDLC) and Electronic Records Regulations (21 CFR Part 11) in a cGXP regulated environment.
• Software Development Life Cycle
• Creation of Standard Operating Procedures for Systems
• Configuration of TrackWise
• Creation of Life Cycle Documents
• Data Mining: Ad-Hoc Querying and Reports (using several mechanisms)
• Change Control

TECHNICAL SKILLS:

Others: TrackWise 7.x and 8.x:Administration, Configuration, Validation, and SOP S

Operating Systems: Microsoft Certified Systems Engineer (NT4), HP UNIX (HPUX)

Databases: Oracle 10/11g, SQL Server, MS Access

Programming: Visual Basic, SQL, Others learned/utilized as required

Reporting: Crystal/Business Objects

Testing Software: HP Quality Center

Document Tracking: SharePoint

PROFESSIONAL EXPERIENCE:

Confidential, Vernon Hills, IL

TrackWise Developer/Validation

Responsibilities:

• 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 Confidential t 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 proper.

Confidential

Senior Consultant

Responsibilities:

• Configuration of Apache Tomcat
• Configuration of Crystal Reports server
• Creation of Crystal Reports
• Creation of SDLC documents (URS, FRS, DS, IQ, OQ, PQ)
• Configuration and Suggested Reconfiguration of TrackWise projects.
• Perform full upgrades to latest versions including supporting software elements.
• Setup of Migration paths

Confidential

Responsibilities:

• Reconfiguration of CAPA and Deviation projects into a global model.
• Revise and create supporting Crystal Reports.
• Performed complete upgrade of their TrackWise 7.0.0 system to version 8.3.2:
• Apache Tomcat configuration
• Crystal Reports Server
• Tweaks of existing Crystal Reports
• Setup of migration paths
• Harmonize individual projects in TrackWise into a global system including an upgrade from TrackWise 7.x to 8.3.
• Creation of several PQ’s to reflect changes in workflows.

Confidential

Computer Systems Validation Specialist-TrackWise Administrator

Responsibilities:

• Revised and created new SOP’s relating to harmonization of standards and updating to current industry practices.
• Successfully guided and assisted contract workers completing the re-validation of TrackWise.
• Successfully performed several other validation projects for other CGXP supporting software: Laboratory Spreadsheets, Corporate Calibration Manager System.
• Successfully designed several quality metric reports and spreadsheets.

Confidential

Laboratory Computer Systems Manager-TrackWise Administrator

Responsibilities:

• Successfully implemented corporate data acquisition systems used for specialized laboratory equipment.
• Completed several supporting SOP’s for the laboratory systems: Backup, Security, etc.
• Created several applications within Excel, Access and Visual Basic for enhancing the laboratory operations.
• Successfully configured and implemented
• Successfully installed and configured NCR, CAPA, CHANGE CONTROL, DEVIATIONS. Validation and implementation not completed, however, due to Confidential Consent Decree at which time I was re-assigned to remediation activities for other GxP systems.
• Successfully configured and implemented the corporate Customer Complaint System including a MedWatch component for Adverse Drug Events.
• Successfully configured and implemented the corporate systems for: Change Control, Corrective Action/Preventative Action, Nonconformance,
• Customer Complaints, Adverse Event Tracking (MedWatch) systems were completed but not placed into production due to initiation of Consent Decree. Successfully directed the design interfaces with the JD Edwards MRP system to improve accuracy, reduce data redundancies, and to provide for bi-directional event links between the two systems that would ensure batch lot status synchronization.
• Successfully upgraded several minor releases.
• Successfully performed several migrations.
• Successfully designed reports for: Quality Metrics, Automatic Periodic reports, and Custom User reports.
• Successfully perform mine, reduce, cross, and present data per user requests using industry standard tools such as Crystal Reports, MS Excel, MS Access, SQL Server Tools.
• Creation of Ad-hoc Crystal Reports for non GxP managerial use utilizing Crystal Enterprise Edition.

Confidential

R&D/Quality Assurance Computer Systems Manager

Responsibilities:

• Successfully configured and implemented full LIMS system for Quality Assurance and R&D.
• Successfully created Quality Metrics and Reporting Systems.

Confidential

Analytical Chemist

Responsibilities:

• Perform Environmental Testing.
• Setup and train on new laboratory equipment.