Overview
Work History
Education
Certification
Timeline
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Stephen R. Gatlin, CMQ/OE, CQA

Colorado Springs,CO

Overview

10
10
years of professional experience
1
1
Certification

Work History

Quality Operations Manager

Octapharma Plasma Inc.
Charlotte, NC
11.2024 - Current
  • Led updates to SOPs, aligning with CFRs and enhancing operational efficiency.
  • Developed and executed waste-reduction project streamlining QCs fleet-wide.
  • Facilitate calls with the corporate medical team to ensure consistency, safety, and reduced errors across the organization.
  • Coordinated efforts and provided support for specialty collection programs.
  • Manage change control for SOPs and projects, from ideation through implementation.

Corporate Auditor

Octapharma Plasma Inc
Charlotte, NC
02.2021 - 11.2024
  • Conducted internal and supplier audits; led and took part in peer reviews.
  • Established and managed training programs for two new Corporate Auditors.
  • Frequently audit and field team contact for CFR requirements.
  • Developed a training template for onboarding new supplier auditors.

Quality Manager

BioLife Plasma Services: Takeda Pharmaceuticals
Addison, IL
08.2015 - 12.2020
  • Mentored 10+ Quality Managers nationwide.
  • Supported in absence of Regional Quality Manager for 6 locations.
  • Successfully lead regulatory audits with > 90% resulting in no observations.
  • Crafted responses pertaining to regulatory findings at center and network level.
  • Opened 2 new plasma collection centers.

Education

Master of Science - Chemistry

Colorado State University
Fort Collins, CO
2014

Bachelor of Science - Chemistry

Colorado State University
2013

Certification

  • Certified Quality Auditor, American Society for Quality - ASQ - 2021
  • Certified Manager of Quality/Organizational Excellence - ASQ - 2025
  • Certified Lean Six Sigma Green Belt - AIGPE - 2025

Timeline

Quality Operations Manager

Octapharma Plasma Inc.
11.2024 - Current

Corporate Auditor

Octapharma Plasma Inc
02.2021 - 11.2024

Quality Manager

BioLife Plasma Services: Takeda Pharmaceuticals
08.2015 - 12.2020

Master of Science - Chemistry

Colorado State University

Bachelor of Science - Chemistry

Colorado State University
Stephen R. Gatlin, CMQ/OE, CQA