Senior Specialist, Sample Management QC

QPS has an immediate opening for Senior Specialist, Sample Management QC supporting our Translational Medicine Department. This role is 100% desk-based. All QC activities are performed through document review, data verification, and system‑based checks. No laboratory or hands‑on QC testing is involved.

The position requires extreme attention to detail, organization, multi‑tasking, and comfort interacting with people who might be junior or senior to the incumbent. The ideal candidate is someone who can share responsibilities and shift priorities when necessary to do what is needed in the moment – especially in a dynamic environment.

QPS's Sample Management Team ensures that client samples and other controlled materials are received, stored, distributed, tracked and returned safely, securely and without loss or damage. The process is regulated and vital to the success of clinical trials around the world.

• Create and maintain Sample Receipt notebooks from creation to archival
• Use our LIMS (database) for tracking of samples through their life cycle at QPS
• Perform QC of Sample Receipt records against an electronic database to ensure they comply with FDA and GLP regulations, client protocol, and QPS SOPs
• Ensure all appropriate GLP paperwork is included with sample receipt packet
• Ensure shipped samples are received and reconciled per client protocol and shipping manifest
• Ensure any referenced client correspondence can be verified
• Monitor documentation of storage changes, disposal, return of samples as needed
• Maintain TLM Sample Receipt Table Request log and communicate any timeline issues internally to Principal Investigator
• Compile and/or perform QC on Sample Receipt tables prior to submission to QA
• QC QPS generated manifest
• QC various Data Management generated reports prior to submitting to Principal Investigator
• Assist SMT with general documentation questions
• Reconcile shipment packets against TLM Dashboard
• Communicate any new SOP revisions to the team and reconcile Employee Qualification Manuals annually
• Understand and abide by HIPAA & GDPR compliant privacy measures

• This job will be 100% QPS-office/facility based

• Combination of relevant education and experience that provides sufficient knowledge and skills to ensure incumbent's success in this role, such as:
  • University/college degree in a relevant scientific discipline and/or
  • Demonstrated experience in CRO, Clinical Research or another relevant field
• Experience in an FDA-related or other regulated industry laboratory is preferred
• Organized, with good detail-orientation
• Proficiency with MS Office, including Excel
• Good interpersonal skills

• 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.
• Structured Career Ladders that provide excellent growth based on your personal aspirations.
• Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
• Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&DD 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.