Lori A. McCool - Sites at Penn State

Lori A. McCool
Tel: 610-384-9428
E-mail: [email protected]
To obtain an interesting and challenging position with a company that will effectively utilize my knowledge of
project management, quality and operations to achieve overall company success.
Areas of Expertise
IT Management and Development
IT Project Development
Team Management
Equipment/Computer System Validation
Inventory Management
Document Control
(FDA, cGMP, PDMA, DEA, Dept. Health)
Create and Manage Training Programs
Disaster Recovery
ISO 9000/9001: 2008 Quality Systems
Operational Quality
Program Development and Management
Regulatory Compliance
Document Specialist
Validation Requirements and
Professional Experience and Key Accomplishments
Project Manager - Pharma client product inventory program implementation and maintenance
Project Manager - On -boarding new client direct mail and pharmaceutical fulfillment programs
Organized and coordinated IT activities for new projects (i.e. website design, file and data base
management and reporting).
Team lead on and FDA compliant pharmaceutical inventory system project, including development,
implementation and validation.
Implemented CAPA program(s) including internal/customer nonconformance trending and tracking system
reducing manufacturing quality costs by 65%
Revised quality programs across three facilities reducing rework costs by 59%.
Created a formalized document control management system incorporating, employee ease of access,
security and online training programs.
Implemented training programs that directly resulted in reduction of customer complaints by 50% and
reduced Nonconformance costs by 65% in three years
Document specialist and writer for Quality Management System including: Quality, Environment and
Security Policies, SOP’s, Training Programs, as well as project management documents such as business
rules and project plans.
Experience in writing URS, Master Plans, Function and Operational Requirements, Traceability Matrix,
Risk Assessments and Test Scripts for IT and validation projects
Performed external Supplier and Internal audits. Directly responsible for all customer and regulatory
Designed an internal master specification reference for specific customer requirements reducing downtime
by 25%
Project Lead for business continuity/disaster recovery planning: incorporating data security, equipment
recovery, and facility/employee alternative solutions.
Employment History
2015 – Present IT Project Development Manager
Encompass Elements, Colmar PA
2013 – 2015
2006 – 2013
1999 – 2006
1998 – 1999
Quality Assurance Manager
Strategic Manufacturing Technologies
Quality Director / Project Manager
Encompass Elements, Colmar, PA
Pharmaceutical Fulfillment/Direct Mail and
Digital Print Shop/Bindery Finishing
Electronics/PCB Contract Manufacturer
Pharmaceutical Fulfillment/Direct Mail and
Digital Print Shop/Bindery Finishing
Quality Assurance Manager
H.S. Crocker Co., Inc., Exton, PA
Pharmaceutical Label Printer
Production Supervisor
Ensoniq Corporation, Malvern, PA
Video and Sound Card Manufacturer
1996 – 1999 Production Supervisor/Quality Auditor
Vishay Inter-Technology, Frazer PA
Networks and Resistors Manufacturer
ASQ Certified Quality Systems Manager
Certified ISO 9000 (2000), Lead Auditor
ASQ (American Society for Quality), Member
Crosby Quality Methods Training
1999- 2005
Crosby Quality College, Graduate
Penn State University
Coursework for BA, IT Project and Operations Management
Expected graduation date Spring 2017
2012 - Present
Coatesville Area Senior High School