Senior Specialist, Sample Management QC

Senior Specialist, Sample Management QC

Full Time Regular Sr Professional-Lab Newark, DE, US

Salary Range: $49,000.00 To $57,000.00 Annually

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 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. Our team is comprised of professionals from diverse backgrounds such as customer service, restaurant/retail, programming, data analysis, and various physical sciences.

We work together to ensure that the biological samples received are stored, logged, tracked, distributed, and reported back to our sponsors per GLP regulations and internal & external SOP requirements.

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work, and are encouraged to achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, team work and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

• 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 HIPPA & 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…