QC Data Reviewer

The QC Data Reviewer plays a vital role in Quality control group and responsible for ensuring compliance with Fujifilms 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 crossfunctional departments. The incumbent must possess a strong understanding of systematic reviews and data integrity with skills and experience in cGMP data review requiring multidepartmental collaboration.

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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.

Reports to QC Compliance Officer

Work Location College Station TX

Primary Responsibilities:

• Perform critical indepth reviews of Quality Control documents including raw data from inprocess 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 crossfunctional 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 timeofuse logs on cGMP instrumentation and audit trails on computer systems used for data acquisition and processing.
• All other duties as assigned.

Qualifications:

• Bachelors degree in Chemistry Biology or related field with 1 years of related experience; OR
• Associates 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 handeye 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 viaemail 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.

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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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or (979)).