Document Control Analyst: eQMS & Quality Compliance Lead

Caris MPI, Inc.

Phoenix (AZ)

On-site

USD 60,000 - 90,000

Full time

12 days ago
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Job summary

Caris Life Sciences seeks a Document Control Analyst to manage the eQMS and ensure regulatory compliance across QA, regulatory, and manufacturing operations. You will oversee document lifecycles, maintain records, and support audits and inspections.

The role involves collaboration with QA, Regulatory Affairs, Manufacturing, and IT to implement changes and drive continuous improvement within the document control processes.

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.
  • 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 compliance with regulatory requirements.
  • Manage document lifecycle: creation, revision, approval, distribution, archival.
  • Maintain physical and electronic files for QMS documents.
  • Prepare and coordinate documentation for internal and regulatory audits.
  • Provide guidance to stakeholders on document control procedures.
  • Collaborate with cross-functional teams to ensure timely revisions and approvals.
  • Identify opportunities for process improvements in document workflows.
  • Assist in training stakeholders on document control practices.

Skills

Document control
Quality systems
eQMS
Regulatory knowledge
MS Word
MS Excel
Outlook

Education

Science degree

Tools

MS Word
MS Excel
Outlook
Internet for business

Job description

Caris Life Sciences seeks a Document Control Analyst to manage the eQMS and ensure regulatory compliance across QA, regulatory, and manufacturing operations. You will oversee document lifecycles, maintain records, and support audits and inspections.

The role involves collaboration with QA, Regulatory Affairs, Manufacturing, and IT to implement changes and drive continuous improvement within the document control processes.

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