Senior Specialist, Sample Report Management at QPS, LLC

Newark, Delaware, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Jul, 26

Salary

0.0

Posted On

17 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sample management, Clinical trials, Regulatory compliance, Watson-LIMS, Data tracking, Quality assurance, Quality control, FDA regulations, GLP, SOP adherence, MS Office, Excel, Attention to detail, Multi-tasking, Interpersonal skills, HIPAA

Industry

Pharmaceutical Manufacturing

Description

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! Our Senior Specialist, Sample Report Management is a key contributor for the smooth operation of the Sample Management Team (SMT) within QPS's Translational Medicine (TLM) department. Sample Management 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. This role requires attention to detail, organization, multi-tasking, and comfort interacting with people at all levels of the organization; we seek a team member who can share responsibilities and do what is needed in the moment – especially in a dynamic environment. 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 Neuropharmacology, 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 achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork 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 (www.qps.com [http://www.qps.com]) for more information and to see all current openings. The Job * Be a point person for QPS specific, Watson-LIMS-based, regulatory compliant, real-time, GBA harmonized sample tracking database and supporting processes * Ensure shipped samples are received and reconciled per client protocol and shipping manifest * Understand and abide by HIIPA & GDPR compliant privacy measures * Monitor documentation of storage changes, disposal, return of samples as needed * Ensure laboratory regulatory compliance with quality, adhering to SOP’s & GLP regulations; direct action including addressing QC/QA audit findings as needed * Interact with and execute tasks on behalf of the Supervisor for Quality Assurance, IT and Facilities * Ensure QPS Sample Receipt records comply with FDA regulations, GLPs and QPS SOPs. Work Location * This job will be 100% QPS-office/facility based Requirements * 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 * Proficient with MS Office, including Excel * Good interpersonal skills 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. * 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 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.

Responsibilities

The Senior Specialist manages the tracking, storage, and reconciliation of client samples within a regulatory-compliant database. They ensure all laboratory operations adhere to FDA regulations, GLP standards, and internal SOPs while coordinating with QA, IT, and facilities teams.