Senior Specialist, 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!

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) were developed to ensure quality laboratory testing and accurate, reliable, and timely test results. Depending on the types of diagnostic tests conducted at a laboratory, that laboratory may need to obtain multiple types of CLIA certificates. QPS is accredited for CLIA high complexity testing in 49 states. QPS performs custom assay development and validation in accordance with both GCP and CLIA to support both diagnostic (e.g. inclusion/exclusion, stratification, etc.) and traditional clinical trial end points. Additionally, the QPS COVID (EUA-approved Thermo Fisher Scientific's TaqPath COVID-19 Combo Kit) molecular diagnostic test is valid for all states.

Job Description

The successful candidate will be a contributing member of the QPS team and will help maintain QPS' federal CMS CLIA Certificate and various state CLIA licenses/permits, as well as support various studies/projects/task surrounding CLIA testing and compliance. This role requires familiarity with the basic requirements of CLIA testing, at both the federal and state levels, FDA's Medical Device Regulations, as well as basic cGCP/cGLP.

Daily Tasks

• Ensure personnel files (CMS CLIA and NYS CLEP) are maintained
• Collect/prepare support documentation to maintain regulatory compliance
• Assist in MediaLab administration
• Generation/issuance of CLIA test results
• Other tasks as assigned

Requirements

• No visa sponsorship (e.g. H‑1B, L‑1, E) will be provided for this active position, now or in the future
• Applicants must currently be authorized to work in the U.S. on a permanent or unrestricted basis

About QPS

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 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!

Job Responsibilities

Maintain testing personnel files (CVs, JDs, and proof of degrees) for CLIA Permits and License Maintenance and Renewal.

Ensure documentation is up-to-date and in compliance of federal CMS CLIA and various state CLIA requirements as well as assist in maintenance of documentation associated with IVD submissions/filings by QPS and/or Sponsor.

Ensure CLIA Director and CLEP Lab Director perform all necessary documentation review.

Assemble the quarterly Quality Management Report.

Perform quarterly Rees Temperature and Humidity assessments for equipment and rooms.

Administer and maintain HIPAA training for new and existing employees.

Assist in maintaining QPS' Media Lab account in support of NYS annual 12 Continuing Education Units (CEU) requirements.

Pull QC data from Watson (or other applications) for trending and CLIA/CLEP Lab Director review.

Maintain and organize documentation related to IVD tracking and any related filings.

Support CLIA Testing for Clinical Trials and QPS Projects, which includes:

• Setup and maintain approved list of test result recipient
• Generate and distribute CLIA test results as required
• QC CLIA test data for test results distribution and data transfer
• Interact/track client requests on data inquiries and ensure appropriate follow-up by appropriate personnel is performed

Work Location

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

Education / Experience

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 other relevant field
• Experience in a Regulated industry laboratory preferred

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.

Equal Employment Opportunity

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.