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1. SCOTT KIRKMAN
Germantown, TN 38139
901.233.8937
ScottKirkman@hotmail.com
www.linkedin/in/ScottKirkman
Summary Government Regulations
Experienced Information Technology Manager with progressive FDA 21 CFR Part 11
leadership in software development and project management. System Validation
Special expertise in developing Supply Chain and Distribution DEA Schedule II
applications. Extensive knowledge in supporting Cold Chain and reporting
Prescription Drug environments. Sarbanes-Oxly (SOX)
Drug Pedigree records
Accomplishments (compliant in 50 states)
Participated in startup of 17 Distribution Centers for 11
customers. Contributed to most or all phases of each project, Supply Chain (WMS)
including requirements gathering, schedule development, gap applications
analysis, software development, testing, training, data SAP WM (SuperUser)
migration, and on-site Go-Live support. Tecsys Inc. EliteSeries
Viastore Provia
Managed both Projects and IT teams. Led teams as large as 5 5 custom-developed
software developers on custom-built software applications in apps
a waterfall approach. Managed installation of Off-the-Shelf
(COTS) software packages with gap analysis and Technical Skills
customization. Responsible for P/L of projects. Project Management
Software Development
Managed multi-function IT departments in production Oracle DBA
support of mission-critical software applications. UNIX Administration
PC support
Assembled IT department while working for a non-IT
supervisor. Created business plan justifying head-count. Warehouse Hardware
Wrote Standard Operating Procedures (SOPs) to define Integration
department operations.
PLC-controlled
Conveyor / Sortation
Configured and purchased computer hardware, servers, and systems
peripherals needed to support mission-critical software
Automated Guided
applications, including Disaster Recovery (DR) capabilities.
Vehicles (AGV)
Automated Storage /
Planned, implemented, and completed FDA system validation
Retrieval Systems
for 2 organizations. Successfully completed multiple Part 11
(AS/RS)
audits by Medical Device / Drug manufacturers.
Radio Frequency (RF)
mobile Terminals
Integral member of H1N1 Swine Flu vaccine distribution
RF encryption
program offered to the public by the Center for Disease
Bar-Code & Optical
Control (CDC) in 2009. 100% of vaccine distributed by the
Scanners
program was handled by Warehouse Management System
Bar-Code printers
(WMS). All shipments requested by CDC to clinics/patients
were delivered on-time, complete, and undamaged. Scales
2. SCOTT KIRKMAN
Experience Computer Languages
McKesson Specialty Health Memphis TN 2002-2013 C++
Largest US Distributor of Prescription Drugs VB
Business Systems Manger SQL
Managed three-person staff, equipment, and applications to support PL/SQL
the division’s data processing requirements. Korn Shell (ksh)
Supported Supply Chain environment including Cold Chain awk
Shipments, 3PL, Schedule II prescription drugs.
Designed and implemented Pedigree electronic record Microsoft Office
retention which provided compliance in all 50 states. Word
Expanded operations from one DC to six DC. Excel
Managed major update of Tecsys WMS with hardware Project
replacement. PowerPoint
Visio
Merck Memphis, TN 1999-2002 Access
Formerly known as Schering-Plough, manufacturer of Over-
the-Counter (OTC) drugs – Claritin, Afrin, Dr.Scholl’s,
Coppertone.
Manager Business Systems
Managed five-person staff and software to support the data
processing requirements of the shipping, transportation, and
manufacturing departments.
Significantly expanded system validation package when FDA
changed industry guidance on Part 11.
Rewrote department SOPs as part of validation.
Implemented SOX when law was passed.
Viastore Grand Rapids, MI 1996-1999
Formerly known as Haushahn as well as Provia, WMS vendor.
Project Manager
Managed multiple projects for external customers. P/L responsibility.
Additional Experience
Project Leader McHugh Freeman Wakesha , WI
UNIX Administrator Digital Equipment Corp. Appleton, WI
Programmer Analyst Ann Arbor Computer Ann Arbor, MI
Education
Michigan State University East Lansing, MI
Masters - Computer Science
Saginaw Valley State University Saginaw, MI
Bachelors - Physics
Certified Lean Specialist Anticipated June 2013