Holly Springs, NC, 27540, USA
7 days ago
Associate Investigator
**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** _7 days ago_ _(9/15/2025 10:59 AM)_ **_Requisition ID_** _2025-35615_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_
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