Investigator, Quality Assurance - QA​/QC, Data Analyst

Investigator 2

Job Location s: US-NC-Holly Springs | Posted Date: 9/15/2025 10:52 AM | Requisition :  | Category:
Manufacturing | Company: FUJIFILM Biotechnologies

The Investigator 2 is responsible to perform major investigations, identify root and contributing causes, contributes to the creation of effective corrective and preventative actions (CAPA) while ensuring timely closure of assigned investigations. This role also supports senior investigators with complex investigations as needed and provides guidance to junior investigators.

• Authors standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness, as needed
• Performs “in operations” duties listed below as required prior to routine operations

• Completes major internal manufacturing investigations to support DSM
• Supports senior investigators with complex investigations, as needed
• Applies systematic causal analysis methods to identify root and contributing causes for assigned investigations
• Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements
• Communicates investigation process to impacted areas, including management, and tracks milestones throughout the investigations
• Partners with key stakeholders during the development of CAPAs to support the investigation process
• Manages investigation workload to ensure closure of investigations within required timeline
• Supports senior investigators during assignment of workload for DSM Deviations Management team, as needed
• Contributes to metric reports to prepare presentations for senior leadership
• Delivers informative and engaging presentations regarding metrics and other relevant information to required stakeholders, as needed
• Provides guidance to junior investigators regarding investigative techniques and best practices
• Other duties, as assigned

• High School Diploma/GED with 9 years of related experience (e.g., investigations)
• Associate’s degree in Life Sciences or Engineering with 7 years of related experience (e.g., investigations)
• Bachelor’s degree in Life Sciences or Engineering with 5 years of related experience (e.g., investigations)
• Equivalent Military experience
• Experience in quality or manufacturing operations
• Prior experience leading manufacturing investigations

• Experience with systematic cause analysis methods (e.g., Event & Casual Factor Analysis, Logic Fault Tree, or similar techniques)
• Root Cause Analysis (RCA) training

• Will work in environment operating a motor vehicle or Powered Industrial Truck
• Ability to discern audible cues
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct work that includes moving objects up to 10 pounds