About the role
Job Summary
The Document Control Specialist is responsible for reviewing, processing, and maintaining quality system documentation in compliance with applicable quality and regulatory requirements. This role ensures the accuracy, consistency, approval, and controlled distribution of documents while supporting cross-functional teams and maintaining the integrity of the document control system within a regulated environment.
Key Responsibilities
- Review, process, and maintain new and revised quality system documents.
- Approve or reject document changes based on established quality procedures.
- Verify document accuracy, consistency, and regulatory compliance.
- Control document access, versioning, and distribution.
- Coordinate document approvals with cross-functional teams and multiple sites.
- Participate in quality and documentation-related projects.
- Maintain document control records within electronic document management systems.
- Support Quality System compliance and follow EHS policies and procedures.
- Identify documentation issues and recommend process improvements.
Required Skills
- Document Control & Quality Documentation
- Quality Management Systems (QMS)
- Regulated Environment Experience (FDA, ISO, GMP preferred)
- Electronic Document Management Systems (EDMS)
- Document Review & Change Control
- Regulatory Compliance
- Database & Computer Software Proficiency
- Strong Written and Verbal Communication
- Organizational & Project Management Skills
- Critical Thinking & Problem Solving
- Cross-Functional Collaboration
- Attention to Detail
- Time Management & Prioritization
- Ability to Work Independently and in Teams
- Minimum
2+ years
of document control or quality documentation experience in a regulated environment. - Experience supporting Quality Systems and documentation processes.
- Familiarity with quality and regulatory standards (FDA, ISO, GMP) is preferred.
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