Confidential, Murrary Hill NJ
Confidential 07/06/10-08/27/10
Trackwise Consultant

• Using TrackWise version 7.0 configured the mapping of the utility eMDR Electronic Regulatory Reporting tool.
• Created the validation IQ script for the TrackWise eMDR Electronic Regulatory Reporting tool.

Confidential, Summit NJ
Confidential Jan2010-Apr 23, 2010
Trackwise Consultant

• Using TrackWise version 7.0 and made configuration modifications to quality tracking systems. (Modifications included: dynamic queries, admin activities types, locked fields, required fields, conditionally required field, dependent fields, notification classes and notification templates)
• Updated the Ondemand CBT software of changes made to the TrackWise system in 2009 and 2010.

Looking for Trackwise Developer position. Mar2009 to Jan2010

Confidential, Summit NJ
Confidential Jan2008-Feb2009
Trackwise Consultant

• Using TrackWise version 6.0 worked on the following projects (Drug Substance, Drug Product, Analytical, Equipment, CAPA, NOE, CRO, Lab Investigation and Lab Investigation - Micro, CFI, Impacted Batch, Extension Request and Hypothesis)
• made TrackWise configuration/modifications to:
• Selection and multi selection fields.
• Made changes to Link Reference field type.
• Modified Terminology field names.
• Modified Terminology PR FlexFields names.
• Modified User Roles and Person Roles
• Modified Group Categories by changing the Can Edit, Insert, Delete and View status for exiting and new fields.
• Modified Person Filter Class Names.
• Modified several Notification Class names and activity types.
• Modified Admin Queries for TrackWise Coordinator notifications.
• Created several Admin Queries and configured the TrackWise Coordinator configuration for sending notifications to specific User Roles.
• Added new reports names to the Report Class names.
• Modified Configforms by adding new fields and changing comments.
• Configured a new project for users review. The project consisted of configuring:
• new fields
• 11 group categories with all field permissions and overall permissions
• workflows for each 11 group categories
• States
• Activities
• Audit trail for all the new fields
• Projects
• User Groups
• Visual Group Categories Classes
• Required Field Classes
• Locked Field Classes
• Activity Notifications
• Developed 3 new metric Crystal Report and modified 6 metric reports and 9 tabular reports.
• Performed Trackwise validation, OQ execution and creation and review of documents.

Confidential, Hopewell NJ
Confidential Nov2004-Dec2007
Trackwise Consultant

• Configured 3 different TrackWise applications in 3 different databases using TrackWise v6.0:

Correspondence Tracking System, CeRTS.

• 1 Division and 3 Projects (Parent/Child)
• Correspondence (Parent record)
• Type of Correspondence
• Commitment
• Loaded all TrackWise software
• Created user and admin Crystal Reports
• Configured and executed:
• TrackWise Person Import utility. Created all flat files for import.
• Created the following documents:
• Created user requirements
• Created design specification
• Created traceability matrix

Dossier Evaluation & Assessment, DEA.

• 1 Division and 11 Projects
• Parent/Child configuration
• DEA is a validated system, CFR21, Part 11
• Crystal Reports
• Created all required user reports
• Created all admin reports
• Configured and executed TrackWise PR Import utility for:
• grid fields
• File attachment fields
• String & selection fields
• Executed Migrator
• Coordinated all installs/upgrades with web server engineer and DBA groups.
• Gathered user requirements
• Provided all details to the MS project plan - dates and time and hooks
• Provided user training and documents
• Created the user requirements; design specification, traceability matrix and OQ documentation.
• Managed all Remedy change requests with the Change Advisory Board for DEA project
• Used TrackWise utilities:
• PR_Import (set utility up as a service)
• Imp_Sel

Renovar Evaluation & Assessment, REA.

• Configured with TrackWise version 6.0
• 1 Division and 3 Projects
• Coordinated upgrades with web server engineering and DBA groups.
• Created/managed all Remedy change requests tickets for REA project
• Gathered user requirements
• Created the design specification document, which acted as requirement document.

Confidential
TrackWise Technical Systems Analyst Jan2003-Nov2004
.
Configured TrackWise versions 4.8 & 4.9 for worldwide company use. All projects were consent decreed and were released on time. Projects are: (CAPA; Audit; Change Authorization; Complaints; Deviation Mgmt System; Legacy data storage) created in one database. TrackWise had 3,000 users. Used TrackWise Coordinator and had over 800 admin queries.

Confidential
Technology Resource Management Sep2002-Jan2003
Trackwise Consultant

Same work stated above when I became an employee of Schering Plough Corp.

Confidential
Product Specialist 2000-2002

Configured all TrackWise Applications at various Pharmaceuticals Companies. Loaded the TrackWise application software at the site. Gathered user requirements. Provided user training. (Worked with 7 pharmaceuticals, 3 technical companies and 2 towns.) At Sparta helped QA dept. with OQ TrackWise. Worked on various TrackWise documentation like TrackWise Coordinator, Admin module, etc.

Confidential
Systems Analyst Feb1983-Jun2000

Held several positions during employment (Final position was a developer of an imaging system which held all nuclear power plant documentation; SOP for operation of Power Plant Control Room.) Created how to documentation for scanning various types of documents (81/2 x11, 11x14, 3x5; drawings & maps; difference color paper) and trained users. Conducted end user trainer, 600 users.

EDUCATION

BS, Business Admin with a concentration in Computer Science
AS, Computer Science