Quality Assurance Project Manager
Resume:
BOB THOMPSON
*** **** ******, ***. *, Zion, Illinois 60099
**************@*****.***
SUMMARY
Dedicated results-driven senior quality assurance professional. Wrote, reviewed and approved FDA-regulated documentation for compliance. Possesses the knowledge and skills in project management, quality assurance, technical writing, and training. Analytical problem-solver, with strong written, verbal and interpersonal skill set. Successful working on cross-functional teams.
EMPLOYMENT HISTORY
CARDINAL HEALTH, Waukegan, IL 2010-2012
Software QA Advisor 7/10 to 5/12
• Ensured regulatory compliance for validated systems
• Led the software validation process for quality-owned systems
• Authored validation documents, developed testing methodologies,
executed test scripts and determined implementation schedules
• Utilized risk assessment techniques in determining the extent of validation activities
• Managed the execution of software system validations and validation deliverables
• Supported systems owners to ensure compliance to the validation process
• Assisted in clarifying system requirements for IT programmers
• Ensured applicable regulatory and Part 11 requirements were met
ABBOTT LABORATORIES, North Chicago, IL 2000-2009
Section Manager/Quality Assurance Group Leader 1/05 to 10/09
• Conducted annual cGMP and validation process training to audiences from 15-150
• Proactively participated in supporting internal/external auditing
• Assured validation documentation compliance with quality and regulatory guidelines
• Managed equipment, facilities, utilities and computer-based systems
validation review boards
• Reviewed, edited and approved validation plans, trace matrices, user requirements, functional specifications, design specifications, IQ/OQ/PQ documents and risk assessments
• Utilized the CAPA electronic system as both a reviewer and approver
• Served as a QA Subject Matter Expert (SME) on a successful two (2) year Quality Management System initiative creating new divisional policies, processes and procedures
• Led initiative resulting in a 50% reduction in validation documentation review time.
• Served as an SME for process improvements and risk-based validation initiatives
Senior Quality Assurance Validation Engineer 12/01 to 1/05
• Chaired Computer-Based and Equipment/Facilities/Utilities Validation Review Boards.
• Reviewed and approved software documentation deliverables
• Reviewed and approved equipment, facilities and utilities documentation deliverables
• Developed and wrote standard operating procedures
• Assured validation documentation compliance with cGMP and quality guidelines
• Conducted GLP/GMP risk assessments and safety training
Quality Assurance Engineer (Kelly Scientific) 6/00 to 12/01
• Reviewed and approved facilities, utilities, equipment documents for compliance as part of a remediation initiative
• Chaired Computer-Based and Equipment/Facilities/Utilities Validation Review Boards.
• Reviewed and approved software validation deliverables
• Designed quality assurance training modules and participated on cross functional teams
BAXTER HEALTHCARE, Round Lake, Illinois 1975-2000
Research Associate I/II, Research Assistant I and Senior Technician
• Summarized complex sterilization data which supported NDA-submissions
• Prepared sterilization sections for NDA new product submissions
• Collaborated with multi-disciplined functions as project manager and focal point
• Managed, scheduled and participated in technology transfers to manufacturing facilities
• Managed IV solutions stability testing program and supervised exempt personnel
• Managed exempt staff serving in a Validation Supervisor capacity
• Managed and wrote technology transfer protocols and reports
• Authored protocols, reports and safety standard procedures
• Supervised a three-shift ethylene oxide sterilization pilot plant operation
• Developed ethylene oxide sterilization cycles for medical devices
• Performed preventive maintenance and equipment calibrations
• Conducted department GLP/GMP risk assessments and safety training
• Supported department management in analyzing and tracking monthly expenses
EDUCATION
B.A, Management, National Louis University, Evanston, Illinois
A.S., College of Lake County, Grayslake, Illinois
TRAINING/SEMINARS
• Query Training and Lean Six Sigma White and Yellow Belt
• Quality Improvement through Defect Prevention & Quality Improvement Process Techniques
• Failure Mode & Effect Analysis and Impact of Defect-Free Work
• Software Quality Assurance Plan and Automated Process Control (APC) Training
• ASQ Manager of Quality/Organizational Excellence
• CAPA User, Reviewer and Approver Training
• Making Difficult Decisions and Leading in a Changing Environment
• Abbott New Leader: Accepting the Challenge and Negotiating to Agreement
• Mastering Your Performance as a Quality Assurance Professional
• Problem Solving and Decision Making With Teams and Team Building Workshop
ADDITIONAL QUALIFICATIONS AND INTERESTS
• Prepared and presented financial concepts courses for non-profit organizations
• Founded a community-based food pantry which operated for eight (8) years
• Served five (5) years as treasurer for a non-profit organization
• Wrote education-related grant proposals resulting in a 100% success rate.
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