The Sr. QC Data Reviewer is 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.

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.

Reports to                QC Compliance Officer

Work Location         College Station, TX 

Primary Responsibilities:

• Perform data reviews on raw materials, release and in-process testing, stability, cleaning verification samples, microbiological testing, instrument calibration records, Contract laboratory results & reports, and analytical test method qualification /verification/transfer/validation. Ensure compliance with internal policies and SOPs as well with cGMPs, GDP, FDA, EMA, and ICH guidelines.
• Lead continuous improvement initiatives to enhance analytical data reporting, adhering to GDP and cGMP standards, while increasing efficiency, compliance, and quality.
• Provide coaching and development to team members, fostering a learning environment to build their skills in data review and compliance with regulatory standards.
• Ensure data integrity and compliance with laboratory procedures, test methods, and protocols, SOPs and work with laboratory personnel to correct documentation errors and promote a cGMP culture.
• Working knowledge and/technical expertise in fields such as protein analysis, plate-based assays, H/UPLC, Electrophoresis, Spectroscopy, Microbiology, Cell cultures, Bioassays and Compendials like Appearance, pH, and Osmolality.
• Review time of use logs on cGMP instrumentation and audit trails on computer systems used for data acquisition and processing.
• Apply strong technical knowledge of various analytical equipment, techniques, and methodologies including liquid chromatography, pH, iCIEF, ELISA, SEC, CE-SDS, and TAMC.
• Prioritize and organize tasks effectively, coordinating with team members for continuous data review process improvements, and provide input to QC analysts for GDP enhancement within cGMP requirements.
• Collaborate with QC Analysts, Group Leaders, and managers across departments as needed.
• All other duties as assigned.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or related fields with 4+ years of related experience; OR
• Associate's degree in Chemistry, Biology, or related fields and 5+ years of related experience.
• 2+ year of cGMP experience required.
• 2+ years of experience in chromatography (e.g. HPLC with empower data acquisition software, UV, and wet chemistry, and/or cell cultures and bioassays) required.
• Experience in or interfacing with a regulated GMP environment preferred.
• 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.
• Communicate effectively through oral and written means and engage positively with clients.
• Demonstrate excellent interpersonal skills and ability to work individually or as part of a team, valuing collaboration highly.
• Manage multiple tasks in a fast-paced environment with clearly defined deliverables and deadlines.
• 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 essential functions.  While performing the duties of this job, the employee is required on a regular basis 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.
• Be available to work weekends and off-shift hours as necessary to support manufacturing activities.
• 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.

*LI-Onsite

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.

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 (FDBTHR@fujifilm.com or (979) 431-3500).