Senior QC Data Reviewer

Position Overview

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.

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

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