FUJIFILM Corporation
Associate Investigator
FUJIFILM Corporation, Holly Springs, North Carolina, United States, 27540
Position Overview
The Associate Investigator assists with and performs minor investigations, root cause analyses, and collaborates cross-functionally. This role ensures theassigned 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 assignedinvestigations
• 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 theinvestigation
• 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.
Job Locations
US-NC-Holly Springs
Posted Date
2 weeks ago
(9/15/2025 10:59 AM)
Requisition ID
2025-35615
Category
Manufacturing
Company (Portal Searching)
FUJIFILM Biotechnologies
The Associate Investigator assists with and performs minor investigations, root cause analyses, and collaborates cross-functionally. This role ensures theassigned 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 assignedinvestigations
• 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 theinvestigation
• 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.
Job Locations
US-NC-Holly Springs
Posted Date
2 weeks ago
(9/15/2025 10:59 AM)
Requisition ID
2025-35615
Category
Manufacturing
Company (Portal Searching)
FUJIFILM Biotechnologies