Document Control Specialist I

College Station, TX - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

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 importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples 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 youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat 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 its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 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: 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:

Bachelors 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 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 committedto 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 ).

Required Experience:

Position OverviewThe 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 pol...