Brief Job Description

The Senior Specialist, LeadInvestigatoris responsible forperforming investigations and driving each event to conclusion by working with others. The Lead Investigator ensures the investigation outcome and root cause analysis are completed ina timely, effective, and compliant manner. The speed and rigordemonstratedby 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.

MinimumQualifications

• 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.

PreferredQualifications

• Bachelor27s 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 ofthe internal core business processes.

• Adept atidentifyingand understanding the critical factorsin order togenerateappropriate solutions.

• Multiple site or function experience

• Familiar with Lean problem-solving tools

Physical & Work Environment

• Work is performed in a combination of office, laboratory, and cGMP manufacturing environments.

Work Schedule: 8 hours - Monday- Friday

The work schedule listed reflects the employee27s expected schedule at the time ofhire. The Company reserves the right tomodifywork schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This position may also include the following conditions: sitting, standing, walking, repetitive motion, and / or wearing personal protective equipment. The items described here are representative of those that must be met successfully to perform the essential functions of this job.