Job Overview
We are seeking a detail-oriented and highly organized Document Control Specialist to join our dynamic team. In this vital role, you will oversee the management, review, and control of critical documentation across various departments, ensuring compliance with industry standards and regulatory requirements. Your expertise will support quality management systems, streamline document workflows, and maintain the integrity of our records. This position offers an exciting opportunity to contribute to a fast-paced environment where precision and efficiency are paramount, supporting our commitment to excellence in manufacturing and regulatory compliance.
Duties
- Maintain and manage all document control processes in accordance with ISO 13485, ISO 9001.
- Utilize document management systems such as SharePoint and ERP platforms to organize, store, and retrieve documents efficiently.
- Review, proofread, and verify technical documents for accuracy, completeness, and compliance with legal and regulatory standards.
- Coordinate document workflows across departments to ensure timely approvals, revisions, and distribution.
- Support records management activities including filing, archiving, data entry, and data management to uphold document integrity.
- Conduct regular audits of documentation for compliance with quality management systems and regulatory requirements.
- Collaborate with cross-functional teams to facilitate document review processes and ensure adherence to project timelines.
Skills
- Strong knowledge of ISO 13485, ISO 9001, FDA regulations, and pharmaceutical regulatory compliance standards.
- Proven experience in document control within the engineering or manufacturing industry.
- Proficiency with SharePoint, Microsoft Office Suite (Word, Excel, PowerPoint), project management software, and ERP systems.
- Must be proficient with ProWorks and CoreWorks.
- Excellent organizational skills with a keen eye for detail; capable of managing multiple priorities simultaneously.
- Effective communication skills for cross-functional collaboration and technical writing.
- Familiarity with document workflow management systems and records management practices.
- Ability to perform proofreading, data entry, and document review accurately while maintaining high standards of quality control.
Join us as a Document Control Specialist to play a crucial role in ensuring our documentation processes meet the highest standards of quality and compliance! Your expertise will help drive operational excellence while supporting our mission to deliver safe, reliable products through meticulous recordkeeping and regulatory adherence.
*** per diem available ***