Associate Investigator

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

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.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll Do

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 casual 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 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 committedto 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 ().

Required Experience:

Position OverviewThe 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.Company OverviewFUJIFILM Biote...