GMP Investigator

Key Accountabilities

• 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).

Skills

• 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

Education and Experience

• BS Degree(Biotechnology, Biology, Chemistry or equivalent)
• Equivalent industry experience, 5-10 years