Document Control Analyst

Caris Life Sciences; Phoenix (AZ); Presencial; USD 60.000 - 90.000; Jornada completa

Descripción de la vacante

Caris Life Sciences in Phoenix seeks a Document Control Analyst to administer the electronic Quality Management System and oversee lifecycle management of controlled documents. You will ensure compliance with FDA, CAP/CLIA, ISO standards and support audits and regulatory inspections.

The role requires experience in document control within regulated settings, strong attention to detail, and effective cross-functional collaboration.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Document control

eQMS

MS Office

Attention to detail

Communication skills

Educación

BS/BA in science

Herramientas

Internet for business

Descripción del empleo

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.

Position Summary

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.

Job Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Physical Demands

Employee may be required to lift up to 30 lbs. Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes, and bio-hazardous material in the lab environment.

Training

All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

At times may be required to work weekends/holidays.

Conditions of Employment

Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation.

Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.