Quality Assurance - Document Control Spec II

  This is an experienced person with in depth and specialized knowledge of cGMP documentation.  This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, assessing document related training requirements and tracking training.  Additionally, they have sufficient knowledge and experience to establish and modify comprehensive document control systems which are compliant with cGMP requirements.  They may be assigned duties representing Quality in appropriate situations as defined by their management. 

External US

Essential Functions

• Processes document routing request forms
• Assigns document control numbers
• Inputs training records and maintains official company training percentages
• Provide draft documents as requested
• Ensure documents are routed to appropriate individuals
• Reviews and makes documents effective
• 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
• Archiving all company documents as necessary
• Assembles, tracks 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

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.
• Ability to access and utilize computer interfaces for extended periods of time.
• Attendance is mandatory.

Qualifications

• Bachelor's degree in a related science concentration with 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
• Associate's degree in a related science concentration with 4 years of experience in a regulated industry, including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
• High School or equivalent 6 years or more of Pharmaceutical or other Regulated Industry experience.

Preferred Qualifications

• Experience with Quality Systems, ie. Trackwise and Master Control

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.