Overview
We are seeking a highly organized and detail-oriented Quality Document Control Specialist to join our dynamic team. In this pivotal role, you will oversee the management, review, and control of critical quality documentation to ensure compliance with industry standards and regulatory requirements. Your expertise will support the integrity of our quality management system, facilitate cross-functional collaboration, and uphold the highest standards of document accuracy and accessibility. This position offers an exciting opportunity to contribute to our commitment to excellence in a fast-paced, innovative environment.
Responsibilities
- Maintain and administer document management systems, including SharePoint and other electronic filing platforms, ensuring all quality documents are current, accurate, and properly stored.
- Review, approve, and control documents such as procedures, work instructions, specifications, and regulatory submissions in accordance with ISO 9001, FDA regulations, and pharmaceutical regulatory compliance standards.
- Manage document workflows from creation through approval to distribution, ensuring timely updates and version control.
- Conduct regular audits of document files to verify compliance with regulatory standards; implement corrective actions as needed.
- Collaborate with cross-functional teams including engineering, manufacturing, and quality control, to facilitate seamless document review processes.
- Ensure proper filing and records management practices are followed for all controlled documents in accordance with industry best practices.
- Support project management efforts by tracking document status updates and maintaining comprehensive records for audits and inspections.
Requirements
- Proven experience in document control within the an ISO 9001 environment, with a strong understanding of document management systems.
- Familiarity with ISO 9001 (quality management systems) FDA regulations, and manufacturing regulatory compliance standards.
- Demonstrated ability to review technical documents for accuracy, completeness, and compliance with legal standards.
- Excellent organizational skills with a keen eye for detail; capable of managing multiple priorities efficiently.
- Proficiency in Microsoft Office suite (Word, Excel, PowerPoint) and project management software tools.
- Strong communication skills to facilitate effective cross-functional collaboration and ensure clarity in document workflows.
- Knowledge of records management principles and data management best practices for maintaining audit-ready documentation.
- Ability to adapt quickly to evolving regulatory requirements while maintaining high standards of accuracy and compliance.
Join us as a Quality Document Control Specialist to play a vital role in ensuring our quality systems operate flawlessly! Your dedication will help uphold our commitment to delivering safe, compliant products while advancing your career within a vibrant organization that values precision and excellence.
Pay: From $26.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
Work Location: In person
