Document Control Specialist

Role Summary

The Document Control Specialist manages the daily operations of issuing, reconciling, and filing controlled documents and records in compliance with the company’s Quality Systems and GxP regulations. This role ensures proper document lifecycle management, accurate recordkeeping, and adherence to procedures. It supports QA functions and coordinates with multiple stakeholders to maintain accessible, compliant documentation.

Responsibilities

• Execute the daily functions of the document control process, including formatting documents, tracking documents through the review/approval cycle, issuing documents for execution, reconciling issued records, and archiving.
• Scan, organize, maintain, and file documents in paper and electronic formats, following the company’s document lifecycle procedures.
• Issue labels for finished products and Quality Control samples.
• Support overall QA functions and perform additional duties as assigned by the supervisor.

Qualifications

• Minimum five (5) years of experience in a regulated work environment.
• Experience with document control systems; experience with Veeva is a plus.
• Experience working within a GxP pharma/biologic environment is a plus.
• Strong understanding and use of Microsoft Office Suite and Adobe Acrobat Pro.

Skills

• Ability to understand and execute on the company's mission and values.
• Exceptional organization skills with strong attention to detail.
• Strong interpersonal skills including clear communication in both oral and written form.
• Demonstrated ability to work with and coordinate demands from multiple stakeholders.
• Exhibition of the highest degree of ethical standards and trustworthiness.
• Responsive, can-do attitude.
• Deals with conflict in a direct, positive manner.
• Ability to think and adapt to a rapidly changing environment and demands.

Education

• High School diploma, Associate or Bachelor's Degree or commensurate experience.