Senior Specialist, Lead Investigator

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, documentingstatusand progress of the investigation. - Authorsreportsthat document the investigation of issues, including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue. - Utilizes theappropriateand approved investigation tools necessary to drive the team to root cause. - Prioritizes work to aid intimelydecisions and completion of investigations. Escalates issues asappropriate. Root Cause & Cross-Functional Collaboration - Seeksandleveragesthe skills and technicalexpertiseof internal and external resources to improve the speed and rigor of investigations. - Collaborates with a cross-functional team todetermine: - Communication strategy so all stakeholders haveappropriate information. - Investigation strategyincludinga clear and actionable problem statement. - Investigation tools. - Investigation action plan and timing. - Root cause. - Solutionselection. - CAPA action plan and effectiveness checks. Minimum Qualifications - Experience in Pharmaceutical Manufacturing and/or other similar regulatedindustry. - 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. - Ability to manage multiple concurrent investigations,monitoringprogress againstobjectivesand timelines to drivetimelyclosure. - Excellent written, verbal, and presentation skills, including technical and investigation report writing. - Ability to work in a fast-paced and rapidly changing environment. - Ability to prioritize work activities to meet customer needs and deadlines. - Ability to take accountability with excellentfollow upand follow through;ownsissues through the full cycle investigation process. - Exercises independent judgment to advance investigations with minimal direction; coaches others and builds cross-functional alignment on root cause and corrective-action decisions. Preferred Qualifications Bachelor's degree, preferably in Science, Engineering, or other related technicaldiscipline. Relevant work experience will be considered in lieu of a degree. 5+ years of experience in a pharmaceutical or other regulated manufacturing environment, including quality investigations and deviation management. Understanding