The role involves maintaining the organization's federal CMS CLIA Certificate and state licenses by ensuring personnel files and regulatory documentation are current and compliant with federal and state CLIA requirements. Daily tasks include managing personnel files, assisting with MediaLab administration, generating CLIA test results, and supporting various studies related to CLIA testing and compliance.
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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 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.
QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.
Market context
Delaware laboratory compliance roles are typically driven by ongoing needs to support CLIA testing, documentation, and regulatory readiness in clinical settings. This role is competitive for candidates who can combine scientific education with knowledge of federal and state CLIA requirements, FDA medical device regulations, and basic cGCP/cGLP. Review the AI-summarized requirements and benefits here to save time versus reading the full posting, then compare your background to the compliance and documentation duties before applying.
