Senior Specialist, Lead Investigator
ResilienceAbout the role
A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Brief Job Description
The Senior Specialist, Lead Investigator is responsible for performing investigations and driving each event to conclusion by working with others. The Lead Investigator ensures the investigation outcome and root cause analysis are completed in a timely, effective, and compliant manner. The speed and rigor demonstrated by the Lead Investigator will drive a culture that prevents unplanned deviations through a robust and proactive investigation process.
Job Responsibilities
Investigation Management & Execution
Conducts organized investigations with a well-defined scope, strategy, and timeline, documenting status and progress of the investigation.
Authors reports that document the investigation of issues, including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
Utilizes the appropriate and approved investigation tools necessary to drive the team to root cause.
Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues as appropriate.
Root Cause & Cross-Functional Collaboration
Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
Collaborates with a cross-functional team to determine:
Communication strategy so all stakeholders have appropriate information.
Investigation strategy including a clear and actionable problem statement.
Investigation tools.
Investigation action plan and timing.
Root cause.
Solution selection.
CAPA action plan and effectiveness checks.
Minimum Qualifications
Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.
Familiarity with cGMP documentation practices and applicable regulatory requirements.
Ability to quickly assess and assimilate technical data and conduct a thorough investigation; ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
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