Senior QC Data Reviewer

The Sr. QC Data Reviewer is 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 data reviews on raw materials release and inprocess 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 platebased 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 CESDS 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:

• Bachelors degree in Chemistry Biology or related fields with 4 years of related experience; OR
• Associates 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 fastpaced 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 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.
• Be available to work weekends and offshift 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 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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