QA Analyst, PQS at FUJIFILM Holdings America Corporation

Holly Springs, NC 27540

About the Job

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB 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 FDB 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.

External US

About the Role:

The QA Analyst, PQS assists in the quality oversight of PQS (Pharmaceutical Quality Systems) applications for the Enterprise Quality Systems administration and document control. The QA Analyst collaborates within the team as well as with other project teams on-site, and with QA departments at other FDB sites. This role focuses on consistent policy administration, assists QA oversight of daily activities, and resolves or mitigates issues that occur during operations. This role maintains relationships with site-based customers and global colleagues, and provide updates as requested.

Major Accountabilities:

Supports QA for project deliverables in accordance with the governing processes and procedures within the assigned Quality area.

Participates in assigned audits on a regular basis.

Reviews and approves test plans and protocols for the validation approach and lifecycle documents.

Monitors procedures, and reports and processes errors.

Documents and communicates test results, defects, and deviations.

Participates in risk assessments and assists in mitigating quality-related risks.

Provides administrative support for the QMS system, as required.

Performs other duties, as assigned.

Basic Requirements:

Bachelor’s Degree in Life Sciences (e.g., Engineering, Applied Science or Chemistry) with no previous experience.

Basic experience or understanding of GMP, GLP, GDP requirements

Preferred Requirements:

Prior experience in GMP environment

Working Environment:

Ability to stand for prolonged periods of time up to 30 minutes.

Ability to sit for prolonged periods of time up to 30 minutes.

Ability to conduct work that includes moving objects up to 10 pounds.

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email

FDBN_PNC@fujifilm.com

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.