GMP Investigator

• The Deviation Investigator Level III is responsible for the investigation and completion of deviations aimed at identification of root cause and implementation of correct actions to prevent recurrence. Level III Investigators are expected to work in a cGMP environment, have working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

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.
• Ability to manage moderate to high workloads with consistent on-time delivery.
• Ability 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.

• 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

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