- 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
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.
- Associates degree AND
- 1 year of Document Control Experience with a basic understanding of pharmaceutical manufacturing systems and terminology
- Bachelor’s degree
- ASQ Certification
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 e-mail FDBTHR@fujifilm.com or call 979-431-3528.