Associate Investigator

About the role

Project Phase: Assist with revising standard operating procedures and work instructions to support operational readiness, as needed. 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. Perform other duties, as assigned.

Responsibilities

• Project Phase: Assist with revising standard operating procedures and work instructions to support operational readiness, as needed.
• 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.
• Perform other duties, as assigned.

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.
• Bachelor’s degree in Life Sciences or Engineering preferred.
• Prior experience in a Good Manufacturing Practice, quality, or manufacturing operations environment preferred.
• No minimum training or certification requirements preferred.
• Root Cause Analysis training preferred.
• BioWork or BTEC Capstone current Good Manufacturing Practice coursework preferred.
• Basic knowledge of systematic cause analysis methods (for example, Event and Causal Factor Analysis, Logic Fault Tree) preferred.
• Willingness to learn to select the appropriate causal analysis tool for each investigation preferred.
• Ability to communicate and collaborate cross-functionally to discuss causal analyses and corrective and preventive actions preferred.
• Good technical writing skills and ability to clearly document findings for minor internal investigations preferred.
• Willingness to build technical interpretation skills from multiple subject matter experts and develop coherent, concise narratives with support from senior investigators preferred.
• Basic knowledge of performance improvement with a foundation in Human and Organizational Performance principles preferred.
• Team-based attitude with the ability to build relationships and work effectively with key stakeholders preferred.
• Basic knowledge of change management, investigations, corrective and preventive actions, and continuous improvement methodologies preferred.

Qualifications

• 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.

Skills

• 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.

Benefits

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.

Pay

N/A

Schedule

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