What are the responsibilities and job description for the Intern: Quality - Inspection Readiness position at FUJIFILM Diosynth Biotechnologies?
The Intern (Quality Assurance (QA)) is part of the Inspection Readiness team tasked with tracking and delivering a sustainable Inspection Readiness Program in alignment with Good Manufacturing Practice (GMP) guidelines. As part of the QA team, the Intern gains firsthand experience with the regulatory requirements of GMP readiness and operations for a biological manufacturing site, tracks cross-departmental timelines and deliverables, and presents status updates to the Quality leadership team.
Start Date: This internship is set to begin in May 2025 for an 11-week duration ending in August 2025.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
Company Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
Job Description
What You’ll Do
Under the direct supervision, support and guidance of the manager:
Fujifilm is committed to 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 (FDBN_PNC@fujifilm.com).
Start Date: This internship is set to begin in May 2025 for an 11-week duration ending in August 2025.
Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.
Company Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
Job Description
What You’ll Do
Under the direct supervision, support and guidance of the manager:
- Collaborates with experienced Quality team members on identified project(s). Creates and delivers presentation on identified project to Site Leadership Team at the conclusion of internship.
- Assists with planning and executing site inspection logistical and tactical implementation plans
- Maintains detailed inspection schedules via Smartsheet, electronic and physical dashboards, and PowerPoint presentations
- Assists with the design of a communication strategy to provide schedule, task, and status updates to the site
- Assists in the coordination of an Inspection Readiness training program
- Maintains dashboard monitoring Inspection Readiness packages for both partner inspections and mock inspection activities
- Prepares and coordinates the departmental deliverables for partner inspection packages, including standard operating procedure (SOP) mapping, schedule integration, and subject matter expert (SME) readiness
- Performs other duties, as assigned
- Currently enrolled in an Associate's Degree program with a Life Sciences focus OR
- Rising Junior or above and enrolled in an Engineering or Scientific Undergraduate or Master’s degree Program
- Proficient in Microsoft Word, Excel, and PowerPoint
- Prior experience in Quality, Regulatory, Project Management or similar departments
- Prior hands-on technical experience (in a laboratory or manufacturing environment)
- Knowledge of GMP operations (in a laboratory or biologics manufacturing space)
- Ability to discern audible cues
- Ability to stand for prolonged periods of time - up to 60 minutes
- Ability to sit for prolonged periods of time - up to 240 minutes
Fujifilm is committed to 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 (FDBN_PNC@fujifilm.com).
