Location: Onsite
Industry: Biopharmaceutical / Manufacturing
Environment: cGMP

About the Role

We are seeking a Deviation Investigator (Levels I-III) to support deviation investigations in a regulated cGMP manufacturing environment. This role is responsible for investigating deviations, identifying root causes, and implementing effective corrective and preventive actions (CAPA) to prevent recurrence.

Level III Investigators will take on more complex investigations and provide guidance to investigation teams while supporting knowledge sharing and continuous improvement across the organization.

Key Responsibilities

• Lead and support deviation investigations from initiation through closure
• Identify root cause and develop effective CAPA to prevent recurrence
• Perform investigations for complex events with support from leadership as needed
• Provide real‑time input for deviation containment and investigative response
• Manage multiple investigations concurrently while meeting established timelines
• Resume in‑progress investigations with limited assistance (Level II-III)
• Provide direction and guidance on investigation approach and methodology
• Facilitate meetings, support cross‑functional collaboration, and resolve conflicts
• Share knowledge to strengthen investigation capabilities and elevate team expertise
• Drive quality outcomes, including achieving Right First Time deviation reviews
• Prepare clear, concise, and compliant investigation reports and documentation
• Perform other duties as assigned

Qualifications

• Experience working in a cGMP manufacturing environment
• Hands‑on experience with deviation investigations, root cause analysis, and CAPA
• Working knowledge of mammalian manufacturing processes (Level III)
• Strong technical writing and documentation skills
• Ability to manage moderate to high workloads with consistent on‑time delivery
• Strong communication, meeting facilitation, and collaboration skills
• Action‑oriented, compliant‑minded, and detail‑focused