Craig Bouchard

About Craig Bouchard

Quality Assurance Manager with a background in Pharmaceutical and Biological production, quality systems, and operational excellence. Strong skills in GMP (GxP) operations, risk assessment, CAPA, process analysis/improvement, change management, project management, problem resolution and product disposition within FDA and international regulatory environments. Demonstrated leadership abilities managing and mentoring diverse teams of professionals. Excellent communication skills both verbal and written, strong analytical thinking ability, self-starter attitude, team player spirit, and detail orientated. Highly organized and dependable individual who thrives under pressure in fast paced environments.

Experience

1. Senior Manager Quality Operations

   Bora Pharmaceuticals

   Feb 2025 — Present · US

Education

• Purdue Global

  BSBA - Supply Chain Management and Logistics

• Missouri Western State University

  Part-time student, pursuit of BSBA-Business-Supply-Chain-Management

Skills

• Manufacturing
• Cross-Functional Team Leadership
• Software Documentation
• Root Cause Analysis
• Electronics
• Process Improvement
• Change Control
• Project Management
• Product Development
• R&D
• Testing
• Computer System Validation
• Process Engineering
• Engineering
• Continuous Improvement
• Automation
• Iso
• Sop
• Fda
• 21 Cfr Part 11
• Engineering Management
• Gmp
• Six Sigma
• Quality Auditing
• Quality Management
• Quality System
• V&V
• Inspection
• Process Simulation
• Validation
• Lean Manufacturing
• Medical Devices
• Capa
• Quality Assurance