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.  

• Ability to manage multiple concurrent investigations, monitoring progress against objectives and timelines to drive timely closure. 

• 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 excellent follow up and follow through; owns issues 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 technical discipline. 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 of the internal core business processes. 

• Adept at identifying and understanding the critical factors in order to generate appropriate 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 employee’s expected schedule at the time of hire. The Company reserves the right to modify work 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.