Scott Buckely

About Scott Buckely

Scott Buckely has 15+ years of experience in the areas of program management, design controls, ERP management, equipment & software validation, cost analysis, SOP and technical writing, as well as personnel training. Mr. Buckely has managed cross functional teams responsible for completion of pharmaceutical investigations, implementation of medical device changes under design control and development of marketing material. Mr. Buckely has prepared and conducted QA reviews and assessments of technical documents supporting investigations, deviations, and CAPAs at pharmaceutical and medical device manufacturing facilities. Mr. Buckely has developed, published and maintained digital and printed marketing material across multiple platforms and has experience working with Joomla and the Adobe Creative Suite. Mr. Buckely has also managed strategic process improvement projects which require project cost analysis, resource planning and budget forecasts. He has also served on a regulatory compliance team and assisted with the preparation and submission of multiple electronic regulatory submissions according to the eCTD lifecycle guidelines through the FDA Electronic Submission Gateway (ESG). Additionally, he has conducted training on ERP navigation and user configuration for technical personnel, provided assistance with the development and execution of ERP software / hardware systems, databases, and IT Policies and procedures, and configured and set up user accounts and customized Intranet and Internet based ERP system. Mr. Buckely received his MBA from Northern Illinois University and his B.B. from Western Illinois University and is a certified Project Management Professional (PMP).

Experience

1. Senior Manager, Document Control and Training

   ICU Medical

   Jan 2021 — Present

Education

• Western Illinois University

  Bachelor of Business, Economics

  2002 — 2006

• Northern Illinois University

  Master of Business Administration (MBA), Business Administration and Management, General

  2009 — 2012

• Northwestern University

  Project Management

Skills

• Photoshop
• Cross-Functional Team Leadership
• Root Cause Analysis
• Regulatory Affairs
• Gmp
• Marketing
• Management
• Regulatory Submissions
• Pmp
• Leadership
• Computer Maintenance
• Economics
• Project Management
• Microsoft Office
• Medical Devices
• Capa
• Change Control
• Testing
• Microsoft Exchange
• Logo Design
• Enterprise Software
• Program Management
• Pharmaceutical Industry
• Sop
• Fda
• Computer Hardware
• Validation
• Quality Assurance
• Quality System
• Cost Management
• 21 Cfr Part 11
• Web Design