SPECIALIZED IN:

Information Engineering, Application Integration/Implementation, Business Intelligence, System Analysis, Computer Systems Validation IQ, OQ, PQ

PROFESSIONAL EXPERIENCE:

Confidential

Crystal Reports Developer

Responsibilities:

• Assess and optimize current TrackWise Web reports and Oracle 10g SQL views
• Create and develop PL/SQL stored procedures, job, programs, schedules and DB links to ease the process of information sharing between systems (ex. JDE and TrackWise)
• Collaborate with business owners in gathering report requirements for all business process workflows (Multi and Single reporting) .
• Develop new Crystal Reports XI Metrics, Crosstabs, Form Layouts, Drilldown, Summary, and Chart reports for Non - Conformance, Change Control (Actions & Inquiries), Commitment Records , Lot Release, Lot Audit History, Certificate Of Implementation and Implementation Action Plan.
• Create, modify, update and document all TrackWise crystal reports.
• Develop Requirements Specifications Documentation, Code Review & Unit Testing protocols for TrackWise reporting and new business workflow processes .
• Provide direction and guidance on how to optimize and develop reports using TrackWise direct table linking, CR SQL commands, Oracle custom views and Oracle table join order

Confidential

Crystal Reports/LabWare LIMS Developer

Responsibilities:

• Developed reports (Metrics, Crosstabs, Form Layouts, Summary, Listing, etc) using Crystal Reports.
• Interact with business owners to gather requirements according to new business processes.
• Manage projects/tasks assigned according to project deliverable dates.
• Develop custom automation scripts, Macros, subroutines (LIMS Basics) to ease user and business process workflows within LIMS.
• Assess current (LIMS) systems processes and makes constructive suggestions for change according to business objectives.
• Project team member in developing and upgrading LabWare LIMS v5 to Labware LIMS v6.
• Developed critical reports (Certificates of Analysis, Certificate of Conformanace, Lot Management, Stability
• Developed customized office automation solutions for querying and filtering LW-LIMS data directly onto preformatted Excel workbooks using Visual Basics and SQL

Confidential

Senior IT Validation/Development

Responsibilities:

• Provide leadership, direction, and management for large-scale enterprise/global technology integrations and process automation such as MOOS, program offices, business process reengineering, and quality/compliance using structured, flexible methodologies to drive projects and immediately deliver benefits.
• Lead project manager for the Implementation of Microsoft Office SharePoint Services (MOSS) and VM ESX 3.5 server that host a mix mode of servers such as Microsoft windows 2003/2008 and Linux servers.
• Define project scope, goals and deliverables that supported the business goals in collaboration with upper management and business sponsors.
• Drafted and submitted budget proposals, and recommend subsequent budget changes where necessary.
• Identify and resolve issues and conflicts within the project team.
• Identify and manage project dependencies and critical path.
• Plan and schedule project timelines and milestones using appropriate tools.
• Track project milestones and deliverables.
• Develop and deliver progress reports, proposals, requirements documentation, and presentations.
• Project manager in installing and configuring a comprehensive Microsoft SQL 2005 Business Intelligence platform providing a bridge between end users and data stores.
• Developed and deployed solution packages, site templates, web parts, list views, dashboards, document library’s and all other necessary configuration for the different site collection configured within MOSS..
• Develop and modify KPIs’, business Data and filter web parts with SharePoint designer or Dreamweaver to facilitate departmental workflow processes within MOSS.
• Create workflow solutions using SharePoint Designer or Visual Studios 2008 to ease information routing and project approvals.

Confidential

LIMS ERD Project Management/Developer

Responsibilities:

• Managed all phases, activities, analytical processes, project timelines and resources for the LabWare LIMS (LW-LIMS) V5 ERD project
• Delivered a logical Entity Relational Diagram (ERD) with an abstract theoretical view of over 400 database tables and how it relates to all Core laboratories, Environmental Monitoring, Investigations, Lot Management, Sample Management and Stability business process workflow used within LW-LIMS V5.
• Project team member in the upgrade of LabWare LIMS v5 to Labware LIMS v6:
• Created, modified and enhanced all LW-LIMS V5.0 business reports performance within Crystal Reports prior to migrating into the new LW-LIMS V6.0 environment.
• Created, modified and enhanced all reports subroutines, access routines and query tags.
• Created, modified, updated and documented all reports database queries/views.
• Developed custom office automation solutions for querying and filtering LW-LIMS data directly onto preformatted Excel workbooks using Visual Basics and SQL.
• Team project member in the execution of operational qualification protocols and Unit Testing scripts for LW-LIMS V6 upgrade.

Confidential

IT Validation/Developer

Responsibilities:

• Team member in configuring Investigation Tracking System (ITS) Projects (NOE, CRO, CAPA, CFI & ER)
• Create/draft an abstract theoretical view of the workflow solution defining activities (action items), record status using Visio
• Oversee project to ensure SDLC quality gates are according to the company’s standard operating procedures.
• Create/Configure TrackWise Workflow solutions to accommodate business processes expectations and needs using TrackWise Web Admin (User Management, System Configuration, Coordinator Configuration, Settings and Notifications) and TeamAcess (Manage ConfigForms )
• Data Fields - Define custom user define fields(UDF’s)
• PR States - Defined workflow iteration milestones/status
• Activity Types - Defined actions available within each project iteration
• Audit Trail Activity Types - Defined triggers to record data fields modifications
• Logins - Defined user credentials (Account Name and Membership)
• Group Categories - Defined security levels and workflow (Activities executed at a given state)
• Projects - Defined record types and its attributes(Classes defined within the configurations section in Web Admin)
• Coordinator - Defined Business Rules(Notifications, Assign To, Records Due, schedules)
• Development of TrackWise 7 systems validation process covering configuration and installation of Change Management (CM) modules.
• Development, design, and configuration of TrackWise application and documentation with business owners and technical team to certify TrackWise QMS meets expected functional requirements (including 21 CFR Part 11 and ER/ES)
• Developed Installation Verification (IV) and Functional Verification (FV) protocols in compliance with company’s standard operating procedures (SOP’s) for TrackWise ITS and CM modules which include the following:
• Number of Events (NOE); Lab Investigation (LI), Contract Research Organization (CRO), Corrective Action and Preventive Action (CAPA), Impacted Batches (IB), Hypothesis, Cross Functional Investigation (CFI) and Extension Request (ER) business processes.
• Gathered and clarified client reporting requirements, business needs via feedback sessions and client meetings, in collaboration with all stakeholders.
• Developed and enhanced critical business reports for TrackWise CM and ITS modules using Crystal Reports XI.
• Developed database views to ease the process overload of business reports.
• Developed Requirements Specifications Documentation, Code Review & Unit Testing protocols for TrackWise reporting.
• Developed and executed reports Unit Test Cases (UTC) that tested the functionality of the business reports within TrackWise ITS and CM modules.

Confidential

Network Validation Support Specialists

Responsibilities:

• Provided information solution and methodology approach in the process of validating information cGMP network systems to comply with 21 CCFR Part 11 FDA regulations
• Developed and executed cGMP network infrastructure assessment and:
• Developed as-is hardware design specification (HDS) documentation
• Inventoried all cGMP network components.
• Developed hierarchy logical Visio diagram of all cGMP network components
• Developed Risk & Impact Assessment documentation
• Developed cGMP network components Operational Qualification (OQ), Performance Qualification (PQ) Protocols based on a risk approach.
• Developed standard operating procedures for Computer System Validation (IQ, OQ, PQ) in accordance with 21CFR PART11
• Developed automated Factor calculation Excel Worksheet with audit trail and built-in security using VB.

Confidential

Senior IT Network Engineer

Responsibilities:

• Developed reports (Metrics, Crosstabs, Form Layouts, Summary, Listing, etc.) using Crystal Reports within a SQL database environment.
• Provided support in maintaining network infrastructure security, stability, reliability and in communication with all company branches
• Project leader in consolidation of servers to single location in Philadelphia, eliminating the need for high cost equipments in each office branch, reducing necessary equipment by 30%.
• Developed standard operating procedures for Computer System Validation (IQ, OQ, PQ) in accordance with Sarbanes-Oxley Act.
• Deployed, administered and published application into the Citrix environment.

Confidential

IT Support Specialists

Responsibilities:

• Designed, supported, configured, installs, and maintains local area network hardware, software, and telecommunications services such as personal computers, system software, software applications, printers, servers, routers, switches, modems, cabling, and Internet service providers.
• Designed and implemented software development plans for various departments, including Operations, Finance, Human Resources, Distribution, Purchasing, and Quality Assurance, using Visual Basic Script, Microsoft SQL, Microsoft Access and Microsoft Office Professional thereby allowing departments to progress with ease, both internally and externally.
• Developed full functional workflow solutions in Lotus Notes in compliance with FDA 21CFR Part 11 using Lotus Script.
• Developed, updated and maintained all company reporting needs using Crystal Reports.
• Supported, modified and maintained all business reports.
• Responded expediently for requests to create, modify and fix business reports.
• Developed complex, production-level reports.
• Translated end user reporting requirements into technical design documents.
• Created SQL database objects to effectively maintain system and reporting data.
• Developed full ASP applications to ease departmental data input and information retrieval.

Confidential

IT Support Specialists/Application Engineer

Responsibilities:

• Design, configure, validate and maintain local area network and wide area network hardware, software, and telecommunications services such as personal computers, server applications, client applications, printers, servers, routers, switches, modems, cabling, and Internet service providers.
• Developed and modified all departmental business reporting needs using Crystal Reports
• Collaborated with business stakeholders in gathering all reporting requirements.
• Developed complex reports according to business objectives.
• Created SQL objects to ease the process of complex reporting.
• Develop standard operating procedures for Computer System Validation (IQ, OQ, PQ).
• Design, implement and monitor all company network services within a mix mode environment of Windows NT/2000 Domain controllers.