Ronald Clark
Winder
Summary
Experienced Operations and Manufacturing Leader with 8 years in parenteral and aseptic pharmaceutical production, deviation investigation, and regulatory inspection readiness. Specializes in GMP compliance, cleanroom operations, and continuous improvement. Skilled in executing manufacturing control strategies and developing technical documentation aligned with FDA, OSHA, and global regulatory standards.
Overview
8
8
years of professional experience
Work History
Continues Improvement Specialist
Takeda Pharmaceuticals
Social Circle
06.2024 - Current
- Lead and facilitate cross‑functional deviation investigations using RCA, FMEA, and structured problem‑solving to identify root causes and implement sustainable corrective actions.
- Achieved 100% regulatory inspection success with zero observations, strengthening site compliance.
- Supported parenteral/aseptic manufacturing operations, ensuring compliance with FDA, OSHA, and internal quality standards.
- Conducted Gemba walks and Practice vs. Procedure evaluations, verifying alignment between documentation and shop-floor execution.
- Coordinated cross-departmental meetings to resolve deviations, streamline material flows, and strengthen process reliability.
- Identified cost-saving initiatives to enhance operational efficiency.
- Utilize TrackWise/Veeva‑equivalent systems for deviation, CAPA, and change management.
- Create, revise, and approve GMP documentation, including SOPs, job aids, and training materials.
Manufacturing Supervisor
Takeda Pharmaceuticals
Social Circle
04.2022 - 06.2024
- Managed staffing, scheduling, and operational decision-making to optimize production flow and resource allocation.
- Led, coached, and developed manufacturing personnel to build a capable and high‑performing team.
- Supervised daily operations in a cleanroom environment (ISO 8/Grade C) ensuring adherence to aseptic technique, safety protocols, and GMP requirements.
- Collaborated with engineering, maintenance, quality, and TS/MS teams to swiftly resolve equipment, process, and compliance issues, minimizing downtime and maintaining operational efficiency.
- Monitored and improved KPIs including throughput, on‑time delivery, productivity, and efficiency.
- Exercised and reinforced Stop Work Authority, promoting a “Safety First, Quality Always” culture.
- Conducted routine Gemba-style walkthroughs to identify and address unsafe acts, process deviations, and improvement opportunities, enhancing overall safety and compliance.
Senior Manufacturing Technician
Takeda Pharmaceuticals
Social Circle
05.2018 - 04.2022
- Organized, scheduled, and directed team activities to enhance aseptic/sterile manufacturing operations.
- Acted as the primary troubleshooting contact for equipment, process, and compliance issues.
- Collaborated with cross‑functional groups to ensure equipment readiness and optimize material flow for improved operational efficiency.
- Generated accurate and timely batch documentation, ensuring compliance with GMP and regulatory expectations.
- Contributed to and occasionally led Continuous Improvement teams focused on process optimization and waste reduction.
Education
GED -
Gwinnett Technical College
Lawrenceville, GA07-2019
Medical Billing Coding Certification - Medical Technology
Everest Institute
Forest Park, GA07-2010
Skills
Process Improvement
Change Management
Lean Methodologies
Data analysis
JDEdwards Accounts Management
Microsoft Power Platform: Power Apps, Power Automate, Power BI
Microsoft Office: Word, PowerPoint, Excel
SOP and Job Aid Management
Team Collaboration and Leadership
Collaboration & Team Building
Problem solving
Timeline
Continues Improvement Specialist
Takeda Pharmaceuticals
06.2024 - Current
Manufacturing Supervisor
Takeda Pharmaceuticals
04.2022 - 06.2024
Senior Manufacturing Technician
Takeda Pharmaceuticals
05.2018 - 04.2022
GED -
Gwinnett Technical College
Medical Billing Coding Certification - Medical Technology
Everest Institute