Website Fujifilm
Fujifilm
Company : Fujifilm
Position Overview:
A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist III for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks.
Reports to Senior Director, QA Compliance
Work Location College Station, TX
Company Overview:
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.” Visit: (url removed)
Job Description:
Primary Responsibilities:
- Work collaboratively with all levels of the FDBT site to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
- Act as an ambassador for FDBT Quality Culture.
- Deputize fronting Data Integrity in customer and regulatory audits (as required).
- Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
- Work as a change agent to compliantly improve existing or introduce new ways of working.
- Strong experience with GMP, manufacturing processes, quality and regulatory requirements.
- Ensure smooth operation of the FDBT Data Integrity program highlighting any issues in a timely manner.
- Provide guidance and advice to ensure Data Integrity remediation actions are successfully completed.
- Provide coaching and training for staff in Data Integrity Principles.
- Engage in global FDB projects and meetings to include being an active participant in work groups, and assessment of existing and new global systems.
- Schedule and perform assessments, gap confirmation and schedule stakeholder follow-up.
- Review pre-purchase of systems and analyze to ensure Data Integrity Compliance.
- Draft FMEAs and lead stakeholder meetings.
- Raise and manage change controls and CAPAs, and drive mitigation and remediation.
- All other duties as assigned.
Qualifications:
- Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA, GMP, GAMP and ISPE.Develop staff to maximize contributions to the team and the company.
- Ability to multitask and easily prioritize work.
- Ability to work independently with little supervision.
- Proficient in Microsoft Excel, Word and PowerPoint.
- All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
- Bachelor’s degree with 3 years or more experience in Pharmaceutical, Biotechnology or other regulated Industry.
- Master’s Degree with 1 year or more experience in Pharmaceutical, Biotechnology or other regulated Industry.
- Involvement in Data Integrity projects during previous roles.
- Ability to collaborate effectively with stakeholders from across the business, at all levels.
- Excellent written and oral communication skills.
- Excellent organizational, analytical, data review and report writing skills.
- Motivated cross functional worker.
- Ability to set and achieve personal performance goals.
- Provide input to departmental objectives.
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:
- Experience prolonged standing, some bending, stooping, and stretching.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
- Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
- Lifting up to 25 pounds on occasion.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Must be willing to work flexible hours.
- Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
- Must be willing to travel occasionally, as needed.
- Attendance is mandatory.
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 ((url removed) or (phone number removed)).