Quality assurance specialist Jobs in College Station, TX

Overview

The work we do at FUJIFILM Diosynth 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 Diosynth 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.” Visit :

Job Description

Essential Functions :

• Leadership
• Work collaboratively with site management to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Mentor peers towards achieving organizational and individual goals.
• Provide guidance and support to teams on compliance-related matters, including training and education initiatives.
• Supervise and mentor a team of QA compliance professionals, providing guidance, training, and coaching as needed.
• Foster a culture of quality and compliance within the team, promoting teamwork, accountability, and continuous learning.
• Lead backroom during inspections as needed.
• Compliance Delivery
• QA support to the organization during internal and regulatory inspections to determine suitability, effectiveness, and compliance with applicable standards and regulations.
• Displays critical thinking expertise, with the ability to define and implement a strategic approach to audit- based on compliance and business knowledge.
• Develop and maintain a robust QA compliance program in alignment with regulatory requirements and best practices.
• Review and update quality policies, procedures, and guidelines to ensure compliance with changing regulations.
• New Business Growth
• Support internal audits as well as regulatory inspections.
• Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
• Compliance
• Ensure self-have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
• Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC, Warehouse and Validations.
• Support Site Readiness Preparation for Regulatory Inspections.
• Staying aware and up to date with agency regulations, guidance documents, and industry best practices, to ensure Fujifilm, Texas site is held to current standards
• Execute audit strategy and lead process audits
• Monitor quality in support of maintaining inspection readiness
• Provides support during regulatory inspections or customer audits as requested by the company, before, during and / or after the event.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Prepare detailed audit and inspection reports documenting findings, observations, and recommendations for corrective actions.
• Ensure accurate and timely documentation of all internal audit and inspection activities, including tracking and follow-up on corrective actions.
• Collaborate with cross-functional teams to address compliance gaps and implement process improvements.
• Ensure audit and inspection reports are responded on time.
• Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors from many sources. Is adept at interpreting GMP regulations in the resolution of problems and in the design of systems, processes or procedures.
• Ability to effectively plan, organize, and execute work that ensures deliverables are consistently met
• Continuous Improvement
• Stay informed about industry trends, regulatory changes, and best practices related to quality assurance and compliance.
• Proactively identify opportunities for process improvement and recommend strategies to enhance the effectiveness and efficiency of quality systems.
• Participate in quality improvement initiatives, root cause analysis, and risk assessment activities.
• All other duties as assigned.

Qualifications :

Preferred Qualifications :

Required Skills & Abilities :

Working Conditions & 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 :

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

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.

EEO Information

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.

ADA Information

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 ( or (979) 431-3500).

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