Jobs · Information Technology · North Carolina

Investigator 1

FUJIFILM Biotechnologies · Holly Springs, NC · 1 wk ago
On-siteInformation TechnologyFull-time

About the role

Join a high-impact team where your curiosity, problem-solving, and drive to improve will make a tangible difference. As an Investigator I, you’ll execute minor internal manufacturing investigations, pinpoint root and contributing causes, and help shape effective corrective and preventive actions (CAPAs) that keep our operations running at their best. You’ll also partner with senior investigators on major investigations—gaining exposure, mentorship, and opportunities to grow.

Responsibilities

  • Complete minor internal manufacturing investigations to support DPFG.
  • Support senior investigators with major investigations, as needed.
  • Develop knowledge and capabilities to perform systematic causal analysis methods (e.g., Event & Causal Factor Analysis, Logic Fault Tree) to identify root and contributing causes.
  • Document clear and concise investigation findings and related actions in alignment with Quality Management System (QMS) requirements.
  • Participate in the development of CAPAs to support the investigation process.
  • Communicate investigation progress and outcomes to impacted areas (including management) and track milestones through closure.
  • Manage your investigation workload to ensure closure within required timelines.
  • Contribute to metric reports and prepare presentations for senior leadership, as requested by senior investigators or management.
  • Participate in performance improvement initiatives grounded in Human and Organizational Performance (HOP) principles.
  • Assist with extrapolating and analyzing data; coordinate recommendations that support both minor and major investigations under the direction of senior investigators or a manager.

Requirements

  • Working knowledge of systematic causal analysis methods (e.g., Event & Causal Factor Analysis, Logic Fault Tree).
  • Ability to identify and apply the appropriate causal analysis tool for each investigation.
  • Strong collaboration skills to work effectively with cross-functional teams during causal analysis and CAPA discussions.
  • Solid technical writing skills with the ability to document detailed, accurate, and clear investigation reports.
  • Team-first attitude; ability to build relationships and partner with key stakeholders.
  • Confident communicator—capable of presenting information and findings to diverse audiences.
  • Ability to interpret technical input from multiple SMEs and craft a coherent, concise narrative with support from senior investigators.

Qualifications

  • 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

Preferred Qualifications

  • Experience applying Event & Causal Factor Analysis, Logic Fault Tree, or similar root cause methodologies.
  • Prior involvement in CAPA development and effectiveness verification.
  • Exposure to Human and Organizational Performance (HOP) principles.
  • Experience contributing to investigation metrics and leadership presentations.
  • Familiarity with QMS documentation standards.

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