Quality & Compliance Specialist — QMS & Audits

Versiti, Inc.; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Versiti, Inc. seeks a Quality Compliance Specialist to support the Quality department in quality, compliance and regulatory affairs. The role partners with service lines to provide quality input and helps ensure adherence to applicable standards.

The position emphasizes internal audits, data tracking for QMS, and continuous improvement initiatives, with a focus on regulatory readiness across diverse healthcare operations.

Qualifications

• HS Diploma with 4–6 years of QA/QC or Auditing experience in blood banking, pharma, medical devices, or hospital setting
• Associate's Degree with 2–4 years in QA/QC or auditing in related field
• Bachelor's Degree required in relevant life sciences or engineering discipline

Responsibilities

• Support Quality Plan execution and ensure regulatory compliance.
• Identify and implement quality system improvements.
• Prepare quality metrics charts and communicate results.
• Conduct internal audits and track data for QMS elements.
• Assist with Quality Management Review and problem surveillance.
• Ensure service lines comply with QMS requirements and SOPs.
• Provide back-up support to Quality specialists and leadership.

Skills

Quality Assurance

Regulatory Knowledge

GxP Awareness

Documentation

Education

Bachelor's Degree in Clinical Laboratory Science or life sciences

Associate's Degree in Clinical Laboratory Science or allied discipline

High School Diploma

Tools

Microsoft Suite (Word, Excel, PowerPoint)

Electronic Quality Management Systems (EQMS)

Job description

Versiti, Inc. seeks a Quality Compliance Specialist to support the Quality department in quality, compliance and regulatory affairs. The role partners with service lines to provide quality input and helps ensure adherence to applicable standards.

The position emphasizes internal audits, data tracking for QMS, and continuous improvement initiatives, with a focus on regulatory readiness across diverse healthcare operations.