SUMMARY:

The QA Specialist III, QA Compliance, will be responsible for the review and approval of commissioning/qualification/Compliance protocols, reports, computer automation Compliance protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Compliance, will handle all associated responsibilities in compliance with FUJIFILM quality policies and site SOPs to ensure regulatory compliance.
Reports to Manager, 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: https://www.fujifilm.com/us/en/about/region/careers
Job Description:

QUALIFICATIONS:

• Master’s Degree with 2+ years of experience in Pharmaceutical or other regulated Industry; OR
• Bachelor’s degree with 3+ years of experience in Pharmaceutical or other regulated Industry; OR
• Associate’s degree with 5+ years of experience in Pharmaceutical or other regulated Industry; OR
• High school or equivalent with 8+ years of experience in Pharmaceutical or other regulated Industry.
• Experience with qualification/computer Compliance experience.
• Experience with qualification/Compliance of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP’s for GMP facilities.
• Single Use and Process Compliance a plus.
• 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.
• 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.
• 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 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, weekends as needed.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory.

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 (FDBTHR@fujifilm.com or (979) 431-3500)

PRIMARY RESPONSIBILITIES:

Leadership

• Provides QA support to the Compliance 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.
• Knowledge and understanding of Computer cGMP regulations and practices pertaining to computer Compliance principles, manufacturing processes, quality systems, engineering design fundamentals, SOPs, regulatory agency expectations and industry trends.
• Reviews computer test automation scripts, creation, and deviation closure recommendations as required.
• Set up and maintain QA Compliance Monthly Tracker.

New Business Growth

• Support client due diligence and Quality audits as well as regulatory inspections.

Compliance

• Reviews and approves master plans, pre/post approval of qualification and Compliance protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
• Reviews and approves qualification and Compliance 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 Compliance, Metrology, Facilities, Engineering, on a daily basis 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.

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, weekends as needed.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory