Senior Specialist, Laboratory Compliance Support (CLIA)

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you!

QPS’s Story

QPS Holdings, LLC is a global, full-service contract research organization (CRO) providing discovery, preclinical, bioanalytical, and clinical research services to pharmaceutical and biotechnology clients worldwide. Founded in 1995, QPS has grown into an award-winning CRO supporting drug development programs across the globe. Our teams work collaboratively to deliver high-quality data that helps advance new therapies.

The Job

The Senior Specialist, Laboratory Compliance Support (CLIA) provides documentation management, record maintenance, and administrative support for CLIA-regulated laboratory activities within the Translational Medicine department. This role works closely with and 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. The position also supports operational activities related to CLIA testing for clinical trials and internal projects.

This is an individual contributor role focused on documentation management, compliance tracking, and laboratory administrative coordination in a regulated environment - ideal for someone who enjoys organizing complex documentation and maintaining detailed records in a regulated environment. You’ll gain hands-on exposure to CLIA compliance, laboratory quality systems, and clinical trial testing while helping keep our laboratory organized, compliant, and inspection-ready in support of research advancing new medicines and therapies.

• Key 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
• Assist with 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