Document Control Analyst

At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care-we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: "What would I do if this patient were my mom?"

That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.

The Document Control Analyst is primarily responsible for the administration and management of the Document Control system within the electronic Quality Management System (eQMS). This role ensures compliance with regulatory requirements and supports quality, regulatory, laboratory, and manufacturing operations by overseeing document lifecycle processes and contributing to continuous improvement initiatives.

• Administer and maintain the Document Control system to ensure full compliance with applicable domestic and international regulatory requirements and standards (e.g., FDA, CAP/CLIA, ISO 13485, ISO 15189).
• Manage document lifecycle activities, including creation, revision, approval, distribution, and archival of controlled documents.
• Maintain physical and electronic files for both active and archived records of all relevant QMS documents.
• Prepare and coordinate documentation for internal audits, client audits, and regulatory inspections.
• Serve as a resource for QMS-related documentation requirements and provide guidance to internal stakeholders.
• Collaborate with cross-functional teams to ensure timely completion and approval of document revisions.
• Identify opportunities for process improvements within document control workflows and assist in implementation.
• Provide guidance and training to stakeholders on document control procedures, system usage, and regulatory expectations.
• Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, Information Technology, and other departments to ensure effective implementation of changes.
• Support periodic reviews of document management procedures and recommend process improvements based on industry best practices and regulatory expectations.
• Maintain electronic and physical records associated with document control activities in accordance with record retention requirements.

• 1-3 years of experience in document control or quality systems within a regulated environment.
• BS/BA in a science-related field or equivalent experience.
• Experience working within an electronic Quality Management System (eQMS).
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication skills.
• Strong attention to detail and ability to maintain accurate records.

• Proficiency working within an electronic Quality Management System (eQMS).
• Working knowledge of applicable FDA, CAP/CLIA, EU regulations, and ISO standards.
• Strong proofreading and document formatting skills, including processing of controlled documents (new documents, revisions, obsolescence).
• Ability to work independently with minimal supervision and manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills, attention to detail, and strong decision-making abilities.
• Ability to interpret regulations and guidance documents and apply critical thinking to evaluate requirements.
• Experience participating in continuous improvement and operational excellence initiatives.

Employee may be required to lift up to 30 lbs.…