Associate Investigator

Position Overview

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.

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:

Job Description

What you'll do

Project phase:

• 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.

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.

Minimum qualifications (education and experience)

• 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

Preferred qualifications (education and experience)

• Bachelor's degree in Life Sciences or Engineering
• Prior experience in a Good Manufacturing Practice, quality, or manufacturing operations environment

Training and certification

• No minimum training or certification requirements
• Preferred: Root Cause Analysis training; BioWork or BTEC Capstone current Good Manufacturing Practice coursework

Knowledge, skills, and abilities

• 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

Why this role matters

• Make an immediate impact by helping close investigations on time and to quality standards
• Learn industry-recognized root cause methods and Quality Management System practices
• Partner with experienced investigators and broaden your exposure across manufacturing and quality

Ready to grow as a trusted problem solver and collaborator? Apply today.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. 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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on hirelifescience.com).