Associate Investigator

The Associate Investigator assists with and performs minor investigations, root cause analyses, and collaborates cross-functionally. This role ensures the assigned investigations are completed timely and provides support to senior investigators, as needed.

Job Description

What You’ll Do

Project Phase (Through Mid-2026)

• Assists with revising standard operating procedures (SOPs) and work instructions (Wis) to support operational readiness, as needed
• Performs any “in operations” duties listed below that are required prior to routine operations
  
  

Operations (Starting Mid-2026)

• Completes minor internal manufacturing investigations to support DSM with direction from senior investigators or management
• Assists senior investigators with major investigations, as needed
• Develops knowledge and capabilities to perform systematic casual analysis methods to help identify root and contributing causes for assigned investigations
• Documents investigation findings and related actions in alignment with Quality Management System requirements
• Participates in corrective and preventive action (CAPA) discussions to support the investigation process
• Communicates investigation process to impacted areas, including senior investigators and/or management, and tracks milestones throughout the investigation
• Organizes and prioritizes investigation workload to ensure closure of minor investigations within required timeline
• Assists with preparing metric reports for senior leadership, as requested by senior investigators or management
• Other duties, as assigned
  
  

Basic Requirements

• High School Diploma/GED with 4 years of related experience (e.g., investigations); OR
• Associate’s degree in Life Sciences or Engineering with 2 years of related experience (e.g., investigations); OR
• Equivalent Military experience
  
  

Preferred Requirements

• Bachelor’s degree in Life Sciences or Engineering
• Prior experience in a Good Manufacturing Practice (GMP), quality, or manufacturing operations
• Root Cause Analysis (RCA) training
• BioWork or BTEC Capstone cGMP coursework
  
  

Working Conditions & Physical Requirements

• 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
  
  

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisitio n. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.