Investigator 1/2 (Experience Based)
About The Position
The Investigator 1/2 performs minor investigations, identifies root and contributing causes, and contributes to the creation of effective corrective and preventive actions (CAPAs) while ensuring timely closure of assigned investigations. This role also supports senior investigators with major investigations and other tasks, as needed. Company Overview 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/GED with 6 years of related experience (e.g., investigations); OR
- Associate’s degree in Life Sciences or Engineering with 4 years of related experience (e.g., investigations); OR
- Bachelor’s degree in Life Sciences or Engineering with 2 years of related experience (e.g., investigations); OR
- Equivalent Military experience
- Experience in quality or manufacturing operations
Nice To Haves
- High School Diploma/GED with 9 years of related experience (e.g., investigations); OR
- Associate’s degree in Life Sciences or Engineering with 7 years of related experience (e.g., investigations); OR
- Bachelor’s degree in Life Sciences or Engineering with 5 years of related experience (e.g., investigations); OR
- Equivalent Military experience
- Experience in quality or manufacturing operations
- Prior experience leading manufacturing investigations
Responsibilities
- Completes minor internal manufacturing investigations to support DSM
- Assists senior investigators with major investigations, as needed
- Develops knowledge and capabilities to perform systematic casual 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
- Participates in the development of CAPAs to support the investigation process
- Communicates investigation process to impacted areas, including management, and tracks milestones throughout the investigation
- Manages investigation workload to ensure closure of investigations within required timeline
- Contributes to metric reports to prepare presentations for senior leadership, as requested by senior investigators or management
- Participates in performance improvement initiatives with a basis in Human and Organizational Performance principles
- Assists with extrapolating and analyzing data and coordinates recommendations to support the investigation process for minor and major investigations under the direction of senior investigators or manager
- Other duties, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
501-1,000 employees
