Senior Specialist, Laboratory Compliance Support (CLIA)

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 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
• 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

Work Location

• This is a fully onsite role based at our QPS facility in Newark, DE.

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

Why You Should Apply

• Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals, with structured Career Ladders that provide excellent growth based on your personal aspirations
• Total rewards package that includes bonuses and merit increases linked to individual, team and company performance. We also offer a solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
• Park-like setting in Newark, Delaware
• Internal committees designed with the needs and enjoyment of QPS employees in mind.

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.