FUJIFILM Biotechnologies
Associate Investigator
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
What Youll Do
The Associate Investigator assists with and performs minor investigations, root cause analyses, and collaborates cross-functionally. This role ensures the assigned investigations are completed timely and provides support to senior investigators, as needed. Project Phase (Through Mid-2026) Assists with revising standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness, as needed Performs any in operations duties listed below that are required prior to routine operations Operations (Starting Mid-2026) Completes minor internal manufacturing investigations to support DSM with direction from senior investigators or management Assists senior investigators with major investigations, as needed Develops knowledge and capabilities to perform systematic causal analysis methods to help identify root and contributing causes for assigned investigations Documents investigation findings and related actions in alignment with Quality Management System requirements Participates in corrective and preventive action (CAPA) discussions to support the investigation process Communicates investigation process to impacted areas, including senior investigators and/or management, and tracks milestones throughout the investigation Organizes and prioritizes investigation workload to ensure closure of minor investigations within required timeline Assists with preparing metric reports for senior leadership, as requested by senior investigators or management Other duties, as assigned Basic Requirements
High School Diploma/GED with 4 years of related experience (e.g., investigations); OR Associates degree in Life Sciences or Engineering with 2 years of related experience (e.g., investigations); OR Equivalent Military experience Preferred Requirements
Bachelors degree in Life Sciences or Engineering Prior experience in a Good Manufacturing Practice (GMP), quality, or manufacturing operations Root Cause Analysis (RCA) training BioWork or BTEC Capstone cGMP coursework Working Conditions & Physical Requirements
Will work in environment operating a motor vehicle or Powered Industrial Truck Ability to discern audible cues Ability to stand for prolonged periods of time Ability to sit for prolonged periods of time Ability to conduct work that includes moving objects up to 10 pounds 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. Seniority level
Entry level Employment type
Full-time Job function
Other, Information Technology, and Management Referrals increase your chances of interviewing at FUJIFILM Biotechnologies by 2x Get notified about new Associate Investigator jobs in
Holly Springs, NC . #J-18808-Ljbffr
The Associate Investigator assists with and performs minor investigations, root cause analyses, and collaborates cross-functionally. This role ensures the assigned investigations are completed timely and provides support to senior investigators, as needed. Project Phase (Through Mid-2026) Assists with revising standard operating procedures (SOPs) and work instructions (WIs) to support operational readiness, as needed Performs any in operations duties listed below that are required prior to routine operations Operations (Starting Mid-2026) Completes minor internal manufacturing investigations to support DSM with direction from senior investigators or management Assists senior investigators with major investigations, as needed Develops knowledge and capabilities to perform systematic causal analysis methods to help identify root and contributing causes for assigned investigations Documents investigation findings and related actions in alignment with Quality Management System requirements Participates in corrective and preventive action (CAPA) discussions to support the investigation process Communicates investigation process to impacted areas, including senior investigators and/or management, and tracks milestones throughout the investigation Organizes and prioritizes investigation workload to ensure closure of minor investigations within required timeline Assists with preparing metric reports for senior leadership, as requested by senior investigators or management Other duties, as assigned Basic Requirements
High School Diploma/GED with 4 years of related experience (e.g., investigations); OR Associates degree in Life Sciences or Engineering with 2 years of related experience (e.g., investigations); OR Equivalent Military experience Preferred Requirements
Bachelors degree in Life Sciences or Engineering Prior experience in a Good Manufacturing Practice (GMP), quality, or manufacturing operations Root Cause Analysis (RCA) training BioWork or BTEC Capstone cGMP coursework Working Conditions & Physical Requirements
Will work in environment operating a motor vehicle or Powered Industrial Truck Ability to discern audible cues Ability to stand for prolonged periods of time Ability to sit for prolonged periods of time Ability to conduct work that includes moving objects up to 10 pounds 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. Seniority level
Entry level Employment type
Full-time Job function
Other, Information Technology, and Management Referrals increase your chances of interviewing at FUJIFILM Biotechnologies by 2x Get notified about new Associate Investigator jobs in
Holly Springs, NC . #J-18808-Ljbffr