Document Control Specialist II

FUJIFILM Biotechnologies; Town of Texas (WI); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Tuition assistance

Job summary

A leading biotechnology company in College Station, TX is seeking a Document Control Specialist II. This on-site role requires expertise in cGMP documentation and the ability to manage document control systems with minimal supervision. Ideal candidates will hold a related Bachelor's degree or equivalent experience in a regulated industry. Benefits include medical and vision insurance, 401(k), and tuition assistance.

Qualifications

• 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products.
• 4+ years of experience in a regulated industry with an Associate's degree.
• 6+ years of experience in Pharmaceutical or Regulated Industry with a High School diploma.

Responsibilities

• Maintain official company training percentages.
• Ensure documents are routed to appropriate individuals.
• Verify and document staff training has been completed as required.

Skills

Excellent written and oral communication skills

Experience with Word

Experience with Excel

Experience with Adobe PDF

Education

Bachelor's degree in a related science concentration

Associate's degree in a related science concentration

High School or equivalent

Tools

Trackwise

Master Control

Job description

Direct message the job poster from FUJIFILM Biotechnologies

***This is an on-site position in College Station, TX. Relocation assistance is not provided.

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.

Reports to Senior Manager, Quality Assurance Compliance Work Location College Station, TX

Essential Functions

• 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.
• Experience with Word, Excel, and Adobe PDF.
• Role model for company core values of trust, delighting our customers, and Gemba.

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

Preferred Qualifications

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

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Tuition assistance

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