Document Control Specialist II

Fujifilm • College Station, TX

8d • Onsite

About The Position

The Document Control Specialist II has 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, the individual who performs this role will 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.

Requirements

• 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.
• 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 with 6+ years or more of Pharmaceutical or other Regulated Industry experience.

Nice To Haves

• Experience with Quality Systems, i.e. Trackwise and Master Control

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees