Document Control Specialist I

The Document Control Specialist I, under general direction, will be responsible for routing and archiving company-controlled documents. Documents include but are not limited to; Standard Operating Procedures (SOPs), production records (PRs), training records, validation documents, and policies.

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

Reports to Senior Manager, Quality Assurance Compliance

Work Location College Station, TX

Essential Functions

• Processes document routing request forms.
• Assigns document control numbers.
• Tracks documents during the routing, review and approval process.
• Assigns effective dates to approved controlled SOPs, PRs, and policy documents.
• Notifies staff of all recently approved documents and identifies training requirements as necessary.
• Verifies and documents staff training has been completed as required.
• Participates in internal audits.
• Assembles and distributes, as appropriate, document requests made during site inspections by an inspecting regulatory agency/representative.
• All other duties as assigned.
  
  

Required Skills & Abilities

• Excellent written and oral communication skills.
• Excellent organization.
• Experience with Word, Excel, and Adobe PDF.
• Role model for company core values of trust, delighting our customers, and Gemba.
  
  

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 sitting, 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.
• Attendance is mandatory.
  
  

Qualifications

• Associates degree AND
• 1 year of Document Control Experience with a basic understanding of pharmaceutical manufacturing systems and terminology.
  
  

Preferred Qualifications

• Bachelor’s degree
• ASQ Certification
• GMP/GLP
  
  

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).