Job Overview
We are seeking a highly organized and detail-oriented Job File Coordinator to join our dynamic team. In this pivotal role, you will oversee the management and maintenance of critical documentation, ensuring compliance with industry standards and regulatory requirements. Your proactive approach will support quality management systems, streamline document workflows, and uphold the integrity of our records. This position offers an exciting opportunity to contribute to a fast-paced environment where precision and efficiency are paramount.
Responsibilities
- Manage and organize all project and production-related documents using document management systems such as SharePoint and ERP platforms.
- Ensure compliance with ISO 13485, ISO 9001, FDA regulations, pharmaceutical regulatory standards, and other legal requirements related to document control and quality management.
- Facilitate accurate data entry, filing, and records management to support audit readiness and regulatory inspections.
- Proofread and review technical documents for accuracy, clarity, and adherence to company standards before approval or submission.
- Maintain detailed records of document versions, revisions, and approvals in accordance with regulatory compliance standards.
- Collaborate with cross-functional teams to streamline document workflows, improve filing systems, and enhance overall data management processes.
- Support technical writing efforts by preparing clear, concise documentation aligned with regulatory requirements and internal quality protocols.
Skills
- Strong knowledge of ISO 13485, ISO 9001 quality management standards, and FDA regulations related to documentation.
- Proficiency in document management systems such as SharePoint and ERP software for efficient data handling.
- Excellent organizational skills with a keen eye for detail to ensure accurate filing, proofreading, and records management.
- Experience with pharmaceutical regulatory compliance and legal standards in production environments.
- Ability to perform data entry accurately while managing large volumes of information within strict deadlines.
- Technical proficiency in using various software tools for document control, data management, and administrative tasks.
- Demonstrated experience in administrative roles requiring meticulous attention to detail, technical writing capabilities, and compliance adherence.
Join us as a Job File Coordinator to play a vital role in maintaining the integrity of our documentation processes while supporting our commitment to quality excellence!
Pay: $14.00 - $20.00 per hour
Benefits:
- 401(k) matching
- Employee discount
Work Location: In person
