Sr Specialist, Quality Assurance

Fujifilm•College Station, TX

1d•Onsite

About The Position

The Sr. QA Validation Specialist will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The Sr QA Validation Specialist, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”

Requirements

Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP’s for GMP facilities.
Excellent written and oral communication skills.
Excellent organizational, analytical, data review and report writing skills.
Ability to set personal performance goals and provide input to departmental objectives.
Ability to lead cross-functional project teams.
Ability to multitask and easily prioritize work.
Ability to work independently with little supervision.
Proficient in Microsoft Excel, Word and PowerPoint.
Must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
Master’s degree preferably in a science-related field with at least three (3) years of related experience , including Operational Quality of Compliance Engineering roles; OR Bachelor’s degree preferably in a science-related field with at least five (5) years of related experience, including Operational Quality of Compliance Engineering roles Associate’s degree preferably in a science-related field with at least seven (7) years of related experience, including Operational Quality of Compliance Engineering roles.
At least three (3) years of cGMP experience or other highly regulated industry.

Nice To Haves

Degree in Engineering or other Science related i.e. Biology, Chemistry or Biotechnology.
Facility Validation, QC, Biotech equipment experience is a plus.

Responsibilities

Provides QA support to the validation team during document review to ensure the organization is complying with local and global quality standards, regulatory requirements, and partner commitments.
Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
Reviews computer test automation scripts, creation, and deviation closure recommendations as required.
Set up and maintain QA Validation Monthly Tracker.
Support client due diligence and Quality audits as well as regulatory inspections.
Reviews and approves master plans, pre/post approval of qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
Participate in design reviews and have experience in reading P&ID’s and various engineering drawings.
Coordinate with Validation, Metrology, Facilities, Engineering, daily to ensure any GMP protocols, requirements etc. are completed in a timely manner.
Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions.
Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
All other duties as assigned