QC Investigator III

Responsibilities

• Share knowledge to significantly enhance performance within the organization with the long term view of constructing sustainable, high performing investigation teams.
• Draws from relevant experience to aid in real-time decisions for deviation containment and investigative response.
• Able to manage moderate to high workloads with consistent on-time delivery.
• Able to resume in-progress investigations with limited assistance from Sr. level investigators.
• Provide direction on deviation approach for the investigators and associated investigation teams, and as this occurs, transfer knowledge to the personnel involved to elevate expertise of the teams.
• Work to achieve >80% Right First Time on customer deviation reviews.
• Drive for effective CAPA such that deviations do not recur.
• Perform investigations for complex events with assistance from team leadership (as needed).
• Perform other duties as assigned.

Requirements

• Ability to work inter-departmentally and with customers.
• High level of area specific operations and technical skills.
• Demonstrates Error Prevention System (EPS) behaviors e.g. 3 way communication, questioning attitude, etc.
• Strong written and verbal communication skills.
• Utilizes multiple RCA tools including but not limited to Cause Mapping, Event and Casual Factor charting, and 5 Why.
• Demonstrate ability for effective Planning, Organizing and Controlling competency.
• Demonstrate sound decision making, considering broad scope of factors.
• Bachelor’s Degree (Biotechnology, Biology, Chemistry or equivalent).
• Equivalent industry experience, 5-10 years.