Root Cause Investigator, Manufacturing Operations

Root Cause Investigator, Manufacturing Operations

As the Root Cause Investigator, Manufacturing Operations, you’ll support and lead the manufacturing organization in root cause analysis and quality event management for monoclonal antibody production. In this role, you’ll partner with cross‑functional teams to lead and support quality event management through investigation, technical writing, continuous improvement, and mentorship to ensure compliance and robust corrective and preventative action.

• Lead root cause investigation for Quality and Safety event management
• Partner with and mentor cross‑functional staff in investigation and technical writing skills
• Deliver technical documentation including summary reports, deviation and change management, procedures, and other manufacturing related documentation
• Lead process improvement kaizens and drive process analytics discussions related to manufacturing KPI
• Uphold strong safety and quality culture

• Education:
  
  Bachelor’s Degree in STEM related field
• Experience:
  
  3 years GMP experience with minimum of 2 years Root Cause Investigation
• Top 2
  
  Skills:
  
  Experience in root cause investigation and hands on GMP experience

• Proven technical writing capability
• Six Sigma Green Belt or higher
• Formal Root Cause Problem Solving training
• Quality event management – Deviation, Change, CAPA etc
• Cross‑functional team work
• Strong coaching/mentorship skills

• Travel: occasional