Resume of IT Manager

Title
IT Manager

Primary Skills
Advanced IT issue resolution, IT Compliance, all Microsoft Servers, SQL and IIS DBA, Laboratory, Microsoft MCSE, Waters

Location
US-PA-Bushkill (will consider relocating)

Posted
Oct-03-07

Specialized Skills: All Databases, Oracle DBA, Microsoft SQL program, and the language. Servers = Windows 3.1, 4.0, 2000, 03, 05, 08, Exchange, All IIS, Enterprise, Advanced DNS Servers, Unix, Apache and Linux.
Client OS= DOS, Windows 3.1, 4.0, 95, 98, 2000, ME, XP, Vista. Also Mac.
Laboratory Systems = Waters Millennium, Empower, Empower2, ChemStation, Compliance Builder, Blue Hill, SOTAX, Windream Software with Leo EVO60 Scanning Electron Microscope (SEM), FTIR, Mass-Spec, LIMS, SAS, Oracle Clinical, AutoCAD, Honeywell Control Systems, Shamatsu Control Systems, Documentum, Qumas, Lotus Notes, JDE, CRM= GoldMine, Act, SalesLogix, Sibel, Microsoft CRM and Microsoft SMS system.

Management Accomplishments


* Executed major project management, overseeing large deployment/configuration for all IT Projects.
* Led Alpharma Site assessments and remediation of US production sites 2002 -2005.
* Successfully passed numerous FDA and Sarbanes-Oxley audits by ensuring that all company systems, processes, policies, and procedures met all compliance and regulatory requirements.
* Project Team1 Direct report 3 consultants to assess and mediate these sites.
* Authored and executed of over 40 SOP's and needed validation documentation for compliance.
* Alpharma FDA Approval with Lasalocid Sodium in Willow Island WV
* Alpharma FDA Approval with Deccoxin Chicago Heights IL
* Willow Island full site assessment, review, budget and Capital Expenditure for new
laboratory Chromatography systems “Waters Empower Network. 3 Servers, 8
Clients”. This project also included GMP and validation of production of the
Honeywell equipment.
* Led training all 21 CFR Part 11, GMP, GLP, and GXP systems at the location.
* Chicago Heights IL full site assessment, review, budget and Capital Expenditure for
upgrade of laboratory Chromatography systems. From Waters Millennium to Waters
Empower Network.
* Led training all 21 CFR Part 11, GMP, GLP, and GXP systems at the location.

* Managed all IT Change control activities for on a divisional level included ensuring FDA and Sarbanes-Oxley requirements are met. This included management, user training, meetings, and audits from FDA and Sarbanes-Oxley.

* Project Lead executed all non-COTS systems. Developed from user requirements custom built software built by Rick Safford.
Custom Built Software
* Analytical and Reference Standards
* Customer Service Complaint system
* Audit System Release
* Regulatory Project tracking system
* SaleQuery: system pulls data from JDE
* KPI System (Key Productivity Indicator} all division 1,200 users
* Alpharma Internets Global http://www.alpharma.com
* Alpharma intranet Global

* Projects Managed and successfully implemented. These systems were purchased directly from vendor, but configuration needed. These projects followed a new implementation process, which included user requirements, vendor contact, vendor audits, project plans, capital budgets, staffing, implementing, and validation.
* Microsoft Project Enterprise Edition 5,000 users
* SalesLogix 2,000 users
* Qumas Document Management System all users
* MSDS System Redshift Technologies
* Empower chromatography
* Regulatory Electronic Submission
* Access database conversions, upgrade to Office XP over 2,000 databases
* Lotus Change Control system

* Team Projects successfully implemented.

* JDE
* Oracle Clinical
* Beckman Lims
* Window XP
* Active Directory
* Server Upgrades
* Member Global Validation Team
* Qumas Change Control Administrators group
* FDA 21 CFR Part 11 voting member 12/2000 through 3/2005


* Microsoft SMS deployment to all validated systems Cordis. Defined and automated deployment process, from two and one half months down to two weeks, major cost savings. Original scope one site grew to currently managing 3 sites for deployment of Microsoft patches to all validated systems.

* Advanced DNS Training and exclusion with Network Solutions

Professional Experience

Cordis (Johnson & Johnson) 5/10/2006 Laboratory and Business Systems Support Lead.
Advanced Laboratory support, responsibilities include support, maintenance, and Administration of all validated Laboratory systems at the Cordis Warren NJ facility.
Chromatography data networks Management, including Waters Millennium, Empower, Empower2, and latest implementation of Waters Acquity system.

Network Solutions 8/15/2005 -- 5/9/2006 Technical Service Specialist
Domain registration: Network Solutions is the largest, and the oldest registrar in the
World. Network has the most DNS Servers worldwide.

Alpharma Inc. Data Program Manager 8/24/2000 -- 3/1/2005
Managed all activities related to the effective development, management, and support of the company's network and computerized systems. Responsibilities included ensuring FDA and Sarbanes-Oxley compliance and direct oversight of applications, databases, e-mail, web, Intranet, server, LANs, WANs, connectivity, disaster recovery, testing, and lab systems. Managed the curriculum of courses, for compliance to meet FDA, and SOX, requirements.

Amano Cincinnati Webmaster 10/13/98 08/13/2000
Internal Division and Online Corporation Reorganization, Web Development and re-construction
Web Presence and Online Advertising Campaigns including Yahoo, Excite, MSN,
Software Implemented, Goldmine, and ACT, CRM based software.

Certifications
Education
Belford University, BS Computer Science

Certifications and Awards

Original certifications go back to Microsoft Sitebuilder Program 1995 to the progression of MSDN.

Microsoft Certified Systems Engineer (MCSE)
Microsoft Certified System Administrator (MCSA)
MCSD Microsoft Certified Solutions Developer VB
MCAD Microsoft Certified Application Developer VB
MCSD.NET Microsoft Certified Solution Developer: Microsoft .NET
Other certifications and training include: Cisco Systems CCNA XP, Active Directory, SQL, SMS, Exchange Interdev, Java, CGI, Pearl, C++, including Microsoft languages, Server Client environments specializing in all database applications including Oracle and Microsoft SQL, MySQL Lotus Applications, Advanced Access database all Office application, UNIX Server PHP, any database type. Other systems include enterprise resource management (ERP) JD Edwards, CRM SalesLogix, Project Management (PMI) Microsoft Project, MSDS Talos Software, compliant label systems, HPLC Chromatography data systems, Waters Millennium Empower, ChemStation, Compliance Builder, Blue Hill, SOTAX, Windream Software with Leo EVO60 Scanning Electron Microscope (SEM), LIMS Validation, SAS, AutoCAD, and all self built software applications.
Microsoft Weekly training and certification courses include
1) Security Updates and vulnerabilities
2) New OS currently on training and deploying Windows Vista along with SQL server 2008

2003-2004 Accommodations from Waters for Innovative Network Design



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