Associate Investigator

Fujifilm•Holly Springs, NC

10d•Onsite

About The Position

Launch your career at the intersection of problem solving, quality, and cross‑functional teamwork. As an Associate Investigator, you will support and perform minor investigations, learn systematic root‑cause techniques, and partner closely with manufacturing, quality, and operations to drive timely, compliant outcomes. You will help ensure investigations close on schedule and provide critical support to senior investigators. FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

High School Diploma or GED with 4 years of related experience (for example, investigations); or
Associate’s degree in Life Sciences or Engineering with 2 years of related experience (for example, investigations); or
Equivalent military experience
Basic knowledge of systematic cause analysis methods (for example, Event and Causal Factor Analysis, Logic Fault Tree)
Willingness to learn to select the appropriate causal analysis tool for each investigation
Ability to communicate and collaborate cross‑functionally to discuss causal analyses and corrective and preventive actions
Good technical writing skills and ability to clearly document findings for minor internal investigations
Willingness to build technical interpretation skills from multiple subject matter experts and develop coherent, concise narratives with support from senior investigators
Basic knowledge of performance improvement with a foundation in Human and Organizational Performance principles
Team‑based attitude with the ability to build relationships and work effectively with key stakeholders
Basic knowledge of change management, investigations, corrective and preventive actions, and continuous improvement methodologies

Nice To Haves

Bachelor’s degree in Life Sciences or Engineering
Prior experience in a Good Manufacturing Practice, quality, or manufacturing operations environment
Root Cause Analysis training
BioWork or BTEC Capstone current Good Manufacturing Practice coursework

Responsibilities

Assist with revising standard operating procedures and work instructions to support operational readiness, as needed.
Perform any “in operations” duties listed below that are required prior to routine operations.
Complete minor internal manufacturing investigations with direction from senior investigators or management to support manufacturing operations.
Assist senior investigators with major investigations, as needed.
Develop knowledge and capabilities to perform systematic causal analysis methods to identify root and contributing causes for assigned investigations (for example, Event and Causal Factor Analysis and Logic Fault Tree).
Document investigation findings and related actions in alignment with Quality Management System requirements.
Participate in corrective and preventive action discussions to support the investigation process.
Communicate the investigation process and status to impacted areas, including senior investigators and management; track milestones throughout the investigation lifecycle.
Organize and prioritize your investigation workload to ensure closure of minor investigations within required timelines.
Assist with preparing metric reports for senior leadership, as requested by senior investigators or management.
Perform other duties, as assigned.