Quality & Compliance Specialist – QMS & Audits

Versit; Indianapolis (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Versiti is seeking a Quality Compliance Specialist to support the Quality department in quality, compliance and regulatory affairs, acting as a liaison between the Quality team and other service lines. The role partners with service lines to provide quality input on projects and everyday tasks.

The successful candidate will help implement the Quality Plan, perform internal audits, track data for the QMS, and support Lean initiatives while ensuring adherence to GDP/QSR standards.

Qualifications

• 4–6 years experience in QMS, QA, QC, or Quality Auditing.
• Experience in blood banking, pharmaceutical, medical devices, or a hospital setting preferred.
• HS Diploma acceptable with relevant experience.
• GxP knowledge preferred (GDP and QSR).

Responsibilities

• Support Supervisor in executing the Quality Plan and ensure regulatory compliance.
• Identify and develop quality system improvements.
• Prepare charts and analyze quality metrics.
• Perform internal audits per schedule.
• Assist with data tracking for QMS elements.
• Participate in Quality Management Reviews.

Skills

Strong communication

Attention to detail

Regulatory knowledge

Education

Bachelor's Degree in Clinical Laboratory Science or related

Associate's Degree in related field

High School Diploma

Tools

Microsoft Excel

Electronic Quality Management Systems

Learning Management Systems

Job description

Versiti is seeking a Quality Compliance Specialist to support the Quality department in quality, compliance and regulatory affairs, acting as a liaison between the Quality team and other service lines. The role partners with service lines to provide quality input on projects and everyday tasks.

The successful candidate will help implement the Quality Plan, perform internal audits, track data for the QMS, and support Lean initiatives while ensuring adherence to GDP/QSR standards.