Senior Specialist CLIA
Senior Specialist CLIA
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Job 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! 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 (EUAapproved Thermo Fisher Scientifics TaqPath COVID19 Combo Kit) molecular diagnostic test is valid for all states
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 FDAs Medical Device Regulations as well as basic cGCP/cGLP.
Daily tasks include 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 and other tasks as assigned.
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 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 www.qps for more information and to see all current openings.
The Job
- Maintain testing personnel files (CVs JDs and proof of degrees) for CLIA Permits and License Maintenance and Renewal.
- Ensure documentation is uptodate 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 followup by appropriate personnel is performed.
Work Location
- This job will be 100 QPSoffice/facility based
Requirements
- University/College Degree in relevant Scientific discipline
- Demonstrated computer proficiency and command of standard Microsoft Office Suite
- Experience with database structure and usage (LIMS Access Quick Base) 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 Companymatched 401(k) and Companysponsored Group Life/AD&D and Short and Longterm Disability Insurance
- Parklike 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.
Required Experience:
Senior IC
Employment Type
Full-Time
