The Deviation investigator Level is responsible for initiating and investigating any Minor, Major, or Critical process deviations aimed at identifying the root cause, determining Product Quality impact (PQI), and implementing correct actions to prevent recurrence. Additional duties include lead representative during audits, project meetings with clients, and daily management meetings when applicable.
- Technical writing for the educated but uninformed reader, translating very complex and challenging scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event and address comments from both internal and external clients on the compiled final report.
- Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assessment of event for impact to SISQP, perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Cause Mapping, and Interviewing.
- Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline, and escalate actions appropriately for resolution in a timely manner. Participation in the Daily Management meetings to update leadership or current deviation statuses.
- Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, Alignment meetings, facilitated reviews, CAPA discussions, Comments resolution.
- Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews.
- Meeting Facilitation and participation, aligning the internal review team and area subject matter experts on an agreed-to investigational path forward. Complex Conflict resolution, problem-solving in a cross-functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty, inclusive of complex technical topics. Attendance and leadership of the daily management system and lead the deviation review board.
Key Requirements:
- Bachelor’s Degree in field of science or diploma with relevant experience
- Skilled in support in supporting pharma process investigations, technical writing, and determining root causes through analysis.
- Extensive background in biopharma production environment regulated by cGMP standards.
- Familiarity with cGMP quality systems.
- Ability to read and comprehend GMP documents (i.e., SOPs, logs, and Batch Records)
- Investigation/Deviation
- Biotech experience in either MFG/QC.
- RCA tools
- Trackwise
- CAPA identification and development
