What are the responsibilities and job description for the Documentation Control Specialist position at RAMPART IC LLC?
Job Overview
As a Document Control Specialist, you will be responsible for managing and maintaining critical documentation in compliance with Rampart standard operating procedures, FDA regulations and ISO13485 quality standards. The Document Control Specialist is responsible for the administration of the electronic Quality Management System software. This position is a leader in document management systems, data entry, and administrative support to ensure accuracy, accessibility, and regulatory compliance across all organizational records. This position reports directly to the Director of Quality Assurance/Regulatory Affairs
Roles And Responsibilities
The Document Specialist plays a vital role in supporting quality management processes and maintaining the integrity of Rampart’s documentation infrastructure.
- Provide administrative support related to document-related projects as needed
- Manage and maintain electronic and paper-based documents using document management systems such as SharePoint and electronic Quality Management software.
- Ensure all documentation complies with ISO 13485, and other relevant regulations and standards.
- Perform data entry, filing, and records management to ensure accurate and accessible documentation.
- Proofread and review documents for accuracy, consistency, and clarity before approval or distribution.
- Support quality management initiatives by organizing and updating procedural documents, work instructions, and policies.
- Assist with document control activities related to Quality Management systems and other technical platforms.
- Collaborate with cross-functional teams to ensure timely updates and proper version control of all documentation.
- Maintain organized filing systems both digitally and physically to facilitate quick retrieval of information.
- Participate in internal audits by providing necessary documentation and supporting records management processes.
- Support technical writing tasks related to standard operating procedures (SOPs), work instructions, and other quality documents.
- Assist in document control activities such as version control, document review cycles, and approval workflows
- Collaborate with cross-functional teams to facilitate document updates and retrievals efficiently
- Provide status reports on various documentation levels to management.
- Review of DCO/ECO packages for adequacy and content
- Complete assignments assigned by Supervisor.
Qualifications Required
A Bachelor or Associate degree in Science or General Studies is required with a minimum of 3 years relevant experience or 5 years relevant work experience. Prior experience in a regulated industry such as medical devices or manufacturing is required
Must be able to occasionally travel to the manufacturing site for audit support.
Skills:
- Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.
- Strong organizational skills with meticulous attention to detail.
- Experience with document management systems such as SharePoint or similar platforms.
- Knowledge of ISO 13485 and ISO 9001 standards related to quality management systems.
- Proficiency in data management, data entry, and records management practices.
- Excellent proofreading, editing, and technical writing skills.
- Familiarity with ERP systems used for document control or quality assurance workflows.
- Administrative experience supporting document control or quality assurance functions preferred.
- Ability to manage multiple tasks efficiently while maintaining accuracy under tight deadlines.