Senior Specialist, Sample Management QC

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.QPS’ Story: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.If this sounds like your ideal work environment, then we would love to speak with you, so apply today! Please visit our website () for more information and to see all current openings.The JobCreate and maintain Sample Receipt notebooks from creation to archivalUse our LIMS (database) for tracking of samples through their life cycle at QPSPerform QC of Sample Receipt records against an electronic database to ensure they comply with FDA and GLP regulations, client protocol, and QPS SOPsEnsure all appropriate GLP paperwork is included with sample receipt packetEnsure shipped samples are received and reconciled per client protocol and shipping manifestEnsure any referenced client correspondence can be verifiedMonitor documentation of storage changes, disposal, return of samples as neededMaintain TLM Sample Receipt Table Request log and communicate any timeline issues internally to Principal InvestigatorCompile and/or perform QC on Sample Receipt tables prior to submission to QAQC QPS generated manifestQC various Data Management generated reports prior to submitting to Principal InvestigatorAssist SMT with general documentation questionsReconcile shipment packets against TLM DashboardCommunicate any new SOP revisions to the team and reconcile Employee Qualification Manuals annuallyUnderstand and abide by HIPPA & GDPR compliant privacy measuresWork LocationThis job will be100% QPS-office/facility basedRequirementsCombination 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/orDemonstrated experience in CRO, Clinical Research or another relevant fieldExperience in an FDA-related or other regulated industry laboratory is preferredOrganized, with good detail-orientationProficiency with MS Office, including ExcelGood interpersonal skillsWhy You Should ApplyGreat 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&D and Short and Long-term Disability InsurancePark-like setting in Newark, DelawareInternal 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.