Senior Specialist, Laboratory Compliance Support (CLIA)

About the role

The Senior Specialist, Laboratory Compliance Support (CLIA) role at QPS is focused on documentation management, compliance tracking, and laboratory administrative coordination in a regulated environment. This role supports the Senior Research Fellow in maintaining CLIA compliance by ensuring that regulatory documentation, personnel records, and quality system materials are accurate, complete, and inspection ready.

Responsibilities

• Maintain CLIA personnel files and regulatory documentation, ensuring records are current, complete, and well organized
• Support the Senior Research Fellow in maintaining CLIA compliance documentation and tracking regulatory requirements
• Aid in renewals and documentation related to CLIA permits, licenses, and laboratory test menus
• Maintain organized filing systems for compliance documentation, quality records, and IVD tracking materials
• Support quality system activities, including documentation coordination, QC data tracking, and preparation of reports
• Assist with administrative aspects of CLIA testing, including maintaining test recipient lists, generating reports, and performing data quality checks
• Track and coordinate responses to internal and client inquiries related to test data and documentation
• Support training documentation, continuing education tracking, and other compliance-related recordkeeping
• Collaborate with internal teams to ensure documentation is accurate, accessible, and audit-ready

Requirements

• Combination of relevant education & experience that provides sufficient knowledge & skills to ensure incumbent’s success in this role, such as: University/College Degree in relevant Scientific discipline, and/or Demonstrated experience in CRO, Clinical Research, or another relevant field.
• Experience in a CRO, clinical research organization, regulated laboratory, or similar life sciences environment preferred
• Experience supporting regulatory documentation, quality systems, or laboratory compliance activities is a plus