Sr. Investigator

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

The Senior Investigator of Deviations Management for Drug Substance Manufacturing (DSM) is responsible to complete major and complex manufacturing investigations identify root cause and create effective corrective and preventive actions (CAPAs). This role engages with regulatory inspectors internal
auditors and senior leadership as needed regarding the findings of investigations. Additionally this role mentors and provides guidance to junior investigators throughout the investigation process.

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

Performs major and complex manufacturing investigations to support DSM
Applies systematic casual analysis methods to identify root and contributing causes for assigned investigations
Documents clear and concise investigation findings and related actions in alignment with Quality Management System requirements
Communicates investigation progress to impacted areas including DSM management
Collaborates with key stakeholders during the analysis of situations and data the root cause analysis (RCA) process and the development of CAPAs to successfully and thoroughly complete manufacturing investigations
Manages investigation workload tracks milestones throughout the process and ensures on-time closure of assigned investigations
Assigns deviations for the DSM Deviations Management team
Mentors junior investigators on the investigation process including the development of the investigation team use of appropriate RCA tools and CAPA development
Leads and participates in process improvement initiatives for the investigation process
Reviews and creates metric reports for senior leadership
Delivers effective informative and engaging presentations regarding investigations metrics etc. to senior leadership or other stakeholders as needed
Engages with regulatory inspectors and internal auditors as needed
Collaborates cross-functionally and across sites to maintain alignment on process and system improvements due to investigative findings and risk analysis
Other duties as assigned

Basic Requirements

High School Diploma/GED with 12 years related experience (e.g. investigations); OR
Associates degree in Life Sciences or Engineering with 10 years of direct experience (e.g. investigations); OR

Bachelors degree in Life Sciences or Engineering with 8 years of direct experience (e.g. investigations); OR
Equivalent Military experience
Experience in quality or manufacturing operations
Prior experience leading complex manufacturing investigations

Preferred Requirements

RCA training

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to discern audible cues
Ability to stand for prolonged periods of time - 30 Minutes
Ability to sit for prolonged periods of time - 60 Minutes
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:

Senior IC

Position OverviewThe Senior Investigator of Deviations Management for Drug Substance Manufacturing (DSM) is responsible to complete major and complex manufacturing investigations identify root cause and create effective corrective and preventive actions (CAPAs). This role engages with regulatory ins...