QC Data Reviewer

Position Overview

The QC Data Reviewer plays a vital role in Quality control group and responsible for ensuring compliance with Fujifilm’s Quality systems, policies, and procedures in accordance with U.S. and international regulatory agencies, ICH, general cGMP, and international guidance. This role involves leading the data review process to ensure accuracy, thoroughness, and timely completion in collaboration with cross-functional departments. The incumbent must possess a strong understanding of systematic reviews and data integrity, with skills and experience in cGMP data review requiring multi-departmental collaboration.

Company Overview

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 FDB and help create 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 FUJIFILM Diosynth Biotechnologies call Genki.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Job Description

The QC Data Reviewer plays a vital role in Quality control group and responsible for ensuring compliance with Fujifilm’s Quality systems, policies, and procedures in accordance with U.S. and international regulatory agencies, ICH, general cGMP, and international guidance. This role involves leading the data review process to ensure accuracy, thoroughness, and timely completion in collaboration with cross-functional departments. The incumbent must possess a strong understanding of systematic reviews and data integrity, with skills and experience in cGMP data review requiring multi-departmental collaboration.

Reports to QC Compliance Officer

Work Location College Station, TX

Primary Responsibilities:

Perform critical in-depth reviews of Quality Control documents, including raw data from in-process, excipients, finished products, stability studies, cleaning verification, instrument calibration records, and contract laboratory results.

Ensure all documents comply with cGMPs and adhere to site operating procedures (SOPs).

Demonstrate a solid understanding of approved SOPs, USP, EP, ICH, and FDA regulatory guidelines.

Support systems and processes to achieve departmental goals and objectives efficiently.

Engage in continuous improvement initiatives to enhance data accuracy and compliance.

Collaborate effectively with cross-functional teams and communicate findings clearly and succinctly.

Assist in maintaining laboratory documentation and manage data within relevant databases.

Undertake other tasks as assigned by management to support departmental objectives.

Review time-of-use logs on cGMP instrumentation and audit trails on computer systems used for data acquisition and processing.

All other duties as assigned.

Qualifications:

Bachelor’s degree in Chemistry, Biology, or related field with 1+ years of related experience; OR

Associate's degree and 2+ years of related experience.

1 year of cGMP experience.

Experience in contract manufacturing or testing organizations, demonstrating the ability to work with clients preferred.

Knowledge of Pharmaceutical analysis preferred.

Six Sigma Black Belt certification preferred.

Applied Human and Operational Performance (HOP) experience preferred.

Experience in contract manufacturing or testing organizations, demonstrating the ability to work with clients.

Knowledge of Pharmaceutical analysis.

Six Sigma Black Belt certification.

Applied Human and Operational Performance (HOP) experience.

Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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:

Regularly experience prolonged standing, bending, stooping, and stretching.

Use hand-eye coordination and manual dexterity for operating office equipment such as keyboards and photocopiers.

Sit for extended periods while working on a computer.

Potential exposure to hazardous chemicals and materials.

Occasionally lift up to 20 pounds.

Onsite attendance is required.

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 ).

FUJIFILM Diosynth Biotechnologies