Summary:

The QC Project Coordinator I will construct, maintain, and oversee the Quality Control Testing Schedule to include release testing, stability testing, and method qualification activities.

The Quality Control Coordinator, under general direction, will be responsible for implementing a Quality Control Master Schedule to guide QC activities supporting batch release and stability testing.  The position will also require frequent communication with the Analytical Development and Assay Method Transfer groups to coordinate and schedule method qualification activities.  The Coordinator will assist the QC Analyst’s and QC Management to navigate GMP documents through the EQMS system.  Close attention to detail is required to update the Master Schedule on a daily basis to ensure QC deadlines and milestones are met.  Other responsibilities may include but are not limited to: Compiling data for Batch Disposition.  Attending planning meetings as needed.  Communicating gaps and schedule changes to QC Area Managers. 

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: https://www.fujifilm.com/us/en/about/region/careers

Essential Functions:

• Construct and maintain a QC Master Schedule
• Assists in preparing QC metrics on a monthly basis
• Alignment of QC Master Schedule to projected manufacturing and stability schedules
• Assist in generating SOW’s and PO’s for external testing
• Work directly with Contract laboratories to coordinate and monitor testing per timelines
• Work directly with customers to update and confirm schedules and deadlines
• Attend daily briefings and update as needed.
• Ability to work cross functionally with Quality Assurance, Manufacturing, and Project Management to establish timelines
• Perform other duties as assigned.

Minimum Qualifications:

• High school or GED and minimum of 4 years between coordinator/management position and GxP experience
• Associates degree and minimum of 2 years total between coordinator/management position or GxP experience
• Bachelor’s degree and minimum of 1 year combined between coordinator/management position and GxP experience (or equivalent)
• Master’s degree

Preferred Qualifications:

• Degree in a scientific discipline
• GMP/GLP experience
• PMP Certificate

Required Skills & Abilities:

• Must be highly organized, driven, and possess the skills and capability to plan ahead and stay on schedule.
• Ability to evolve and adapt to new technologies to include electronic planning tools and Laboratory Information Management Systems (LIMS)
• Computer skills in Microsoft Office and Microsoft Project
• Ability to multi-task and prioritize work assignments with little supervision.
• Excellent attention to detail.
• Ability to work in a team or independent setting and collaborate with employees from various departments.
• Excellent analytical and planning skills.
• Must have excellent organizational, written and oral communication skills.

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:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Attendance is mandatory.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.

If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.

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.

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).