eQMS Document Control Analyst

Caris Life Sciences; Phoenix, Northern (AZ, KY); Hybrid; USD 60,000 - 90,000; Full time

Job summary

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.

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.

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.

Skills

Document control

eQMS

MS Office

Attention to detail

Communication skills

Education

BS/BA in science

Tools

Internet for business

Job description

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.