Linda Waddick
403 Grabill Dr
Westfield, IN 46074
317.289.8830
linda_waddick@lilly.com
Objective
To obtain a position where I can use the skills I have developed during my years working with critical, regulated
systems and gain new experiences and skills, particularly in leadership and resource management. I’m driven to
create successes where I am and would like a position that allows me to grow while also challenging me to think in
new ways.
Skills
 Deployed lab systems to most Eli Lilly and Company
manufacturing sites worldwide.
 Managed local validation deployment for multiple
sites consecutively.
 Extensive knowledge in CSV, QA and QC, CAPA
implementation and monitoring.
 Expert in regulated systems (FDA, EMEA, Japan, etc)
used in R&D, manufacturing, and other critical areas.
 Managed contract staff, coordinated testing and
validation efforts for critical GMP/GLP systems.
 Test experience and knowledge of testing tools such as
Quality Center.
 Created test strategies, test plans, test summary
reports, and defect disposition and resolution.
 Excellent interpersonal communication skills and has a
very outgoing personality.
Employment
SENIOR SYSTEMS ANALYST
Eli Lilly and Company
SYSTEMS ANALYST
Eli Lilly and Company
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DECEMBER 2009 TO PRESENT
Indianapolis, IN
MARCH 2008 TO DECEMBER 2009
Indianapolis, IN
Supported all critical Laboratory Informatics system as Test Lead for system upgrades.
Managed contract staff for the informal and formal review of documentation and testing.
Collaborated with colleagues at all sites using Laboratory Informatics systems to provide consistent support.
Managed the updates and creation of test scripts and test cases utilizing testing tools such as Quality Center.
Responsible for creating test plans, test strategies and test summary reports for new and upgraded systems.
Responsible for all Laboratory Informatics document management, storage, and maintenance.
Responsible for the retirement of critical systems including data extraction and archival, and hardware,
software, and documentation archival.
Managed all Corrective Action Preventive Action (CAPA) actions items for the Laboratory Informatics
team.
Responsible for the investigation of deviations and creation of investigation reports.
Reviewed all change requests and trouble tickets to ensure compliance with departmental procedures.
Responsible for the periodic review and the access roster review of all Laboratory Informatics systems.
Worked with users to review processes in place and suggest (and in some cases, implement) process
improvements.
Created custom project Sharepoint collaboration space to provide customer knowledge base, document
change requests for contract staff, and to provide a central area for project documentation.
Supported all systems under the umbrella of the department as needed
INFORMATION ANALYST
Eli Lilly and Company
DECEMBER 2004 TO MARCH 2008
Indianapolis, IN
All previous duties as well as:
 Manage contract staff for the Global system testing efforts and update, review, and approval of validation.
 Expert SME in creating local validation and determining the local impact of system upgrades to sites.
 Responsible for the creation of all upgrade documentation including validation plans, validation summary
reports, release description/notes, and local instance impact assessment.
 Developed and updated system requirements, modified system design and configuration to reflect the
requirements.
 Extensive testing experience and knowledge of testing tools such as Quality Center, creation of testing
strategies, test plans, test summary reports, and defect disposition and resolution;
 Participated in a Six Sigma project for the improvement of departmental disaster recovery procedures.
 Responsible for the investigation of deviations and creation of investigation reports.
SR. COMPUTER SYSTEM SPECIALIST
Eli Lilly and Company
MARCH 2003 TO DECEMBER 2004
Indianapolis, IN
All previous duties as well as:
 Presented project kick off and wrap up meetings.
 Completed global and local system impact assessments for changes to system requirements, design and
testing.
 Created business continuity plans and disaster recovery plans based upon the business needs at the site.
 Installed system hardware following approved installation protocols.
COMPUTER SYSTEM SPECIALIST
Eli Lilly and Company
MARCH 2000 TO MARCH 2003
Indianapolis, IN
 Collaborated with colleagues at sites including Japan, France, Germany, Spain, Italy, England, and Ireland
for a chromatography system implementation.
 Coordinated and wrote 40 critical system laboratory chromatography validation packages.
 Ensured all documentation complied with departmental, company, and applicable regulatory requirements.
SYSTEM ANALYST
Computer Task Group
JANUARY 1998 TO JANUARY 2000
Indianapolis, IN
 Audited testing results and documentation for 200+ manufacturing applications.
Education
BACHELOR OF SCIENCE, ORGANIZATIONAL LEADERSHIP AND SUPERVISION
Purdue University
MAY 2008
Indianapolis, IN
CERTIFICATE IN HUMAN RESOURCE MANAGEMENT
PURDUE UNIVERSITY
JANUARY 2009
INDIANAPOLIS, IN
MASTER OF SCIENCE, REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS AND MEDICAL DEVICES
NORTHEASTERN UNIVERSITY
TO BE COMPLETED
Q4, 2012