Senior Document Control Specialist at Tempus
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Tempus is currently looking for a Senior Document Control Specialist, to join our Quality Assurance team. This position reports directly to the Quality and Compliance Manager. The role of the Sr. Document Control Specialist is to lead and conduct daily document control activities for all quality and product-related documents & data per standardized practices across Tempus.
- System Administrator of Tempus’ electronic document control system ETQ Reliance.
- Establish and manage proper document review processes.
- Development of controlled documents and procedures pertinent to QA activities and functions as well as other procedures if deemed necessary.
- Maintain all of quality systems documentation, including: QMS/DHF/DMR/DHR/Quality Records.
- Maintain the organizing, indexing, filing, storage and record keeping of all quality systems documentation and quality records in compliance with company policy and regulatory standards.
- Responsible for ensuring only current revisions are available for viewing.
- Timely distribution of latest revision level documents & records to all appropriate users and ensures that obsolete documentation is removed from distribution / publication.
- Ensures proper document classification, sorting, filing and proper archiving.
- Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business during management review.
- Train Document Authors on Good Documentation Practices and Documentation/Records Systems.
- Other duties as assigned.
- Bachelor’s degree in business, sciences, quality management or related field, or equivalent professional experience
- 5+ years of experience in Document Control
- Excellent working knowledge of document control processes, change management and standard practices
- Working knowledge of Good Documentation Practices
- Understanding and working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 820, ISO 13485, ISO 9001, ISO 14971. CAP/CLIA Experience is a plus.
- Ability to operate efficiently and effectively in a fast-paced environment
- Strong attention to detail and highly collaborative
- Ability to communicate at all levels of an organization effectively
- Procedural or Technical writing experience preferred
- Ability to handle confidential information