QC Deviations Investigator / CAPA Specialist

Overview

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you’re ready to help transform the future of medicine, join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 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 :

Job Description

Reports to QC Compliance Officer

Work Location College Station, TX

Primary Responsibilities :

• Leadership
• Work collaboratively with staff and management of site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Participate and support investigations for deviations and incidents.
• Participate in investigations and assist in identification of root and / or contributing causes.
• Ensures required management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action (CAPA) agreement with stakeholders.
• New Business Growth
• Support client due diligence and Quality audits as well as regulatory inspections.
• Compliance
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as assigned.

Qualifications :

Physical Requirements :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to :

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.

EEO Information

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 ( or (979) 431-3500).

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