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CLINICAL LABORATORY QUALITY ASSURANCE SPECIALIST, RESEARCH SCIENTIST / ENGINEER 3

Organization
UW Genome Sciences, Northwest Genomics Center
Job Location
South Foege Building
Seattle, WA 98195
United States
Salary
Commensurate with experience
Benefits

UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for six consecutive years. See: https://hr.uw.edu/benefits/

Job Description

The Northwest Genomics Center (NWGC) at the University of Washington is one of the leading genome centers in the United States. The NWGC, housed in the Department of Genome Sciences, is the largest self-sustaining genome center in the Pacific Northwest and one of the most successful genome centers in the country. It has partnered to deliver exome and/or whole genome sequence (WGS) data for many highly successful large-scale human genetic projects for both rare conditions and common diseases. These projects include the Centers for Mendelian Genomics (CMG), the NHLBI Trans-Omics for Precision Medicine Program (TOPMed) and, most recently, the All of Us Research Program.

The Department of Genome Sciences’ Northwest Genomics Center currently has an outstanding opportunity for a CLINICAL LABORATORY QUALITY ASSURANCE SPECIALIST - RESEARCH SCIENTIST / ENGINEER 3.

Position Purpose:

The CLINICAL LABORATORY QUALITY ASSURANCE (QA) SPECIALIST, a Research Scientist/Engineer 3, will ensure the quality and efficiency of laboratory tests, products and services for a CLIA-certified clinical laboratory performing next generation sequencing, genotyping, and qRT-PCR in the Department of Genome Sciences and the Brotman Baty Institute for Precision Medicine.  As part of a large cutting-edge genomics group, this laboratory provides clinical-grade whole genome, targeted gene sequencing and genotyping of subject-derived samples and interacts with investigators worldwide. The laboratory also supports the Seattle Flu Study by performing molecular testing to detect respiratory pathogens, including SARS-CoV-2.

Responsibilities:

• Create and review laboratory SOPs for processing, test analyses, reporting and maintaining records of subject test results.
• Develop and maintain QC, QA and proficiency for all test documentation.
• Perform primary data quality evaluation and review results.
• Oversee the creation of technical development documentation (validation planning and documentation) for new and updated laboratory tests to specifications required by regulatory agencies
• Participate in the development of novel educational tools/programs for training, maintaining technical competency, and QA/QI.
• Collaborate with existing clinical research units to support ongoing laboratory projects.
• Ensure compliance with all federal and state regulations as well as accreditation requirements that impact laboratory operations.
• Collaborate and review quality control standards and programs; monitor proficiency testing.
• Use LIMs to perform data entry, editing, quality control and quality assurance and other duties as assigned.

Requirements

Requirements include:

• BS/BA in Genetics, Biology, Biochemistry, or a related field
• Three or more years of related work experience with a minimum of two years of experience working in a high-complexity clinical laboratory,
• In-depth understanding of quality management concepts and regulatory/accreditation requirements
• Extensive experience with laboratory Quality Management programs, particularly QA/QC procedures as related to CLIA, CAP, FDA and other regulatory bodies
• Strong analytical and problem-solving skills
• Excellent written, verbal and interpersonal communication skills
• Must be highly organized with a strong attention to detail
• Open to receiving direction and to ask for assistance when needed
• Ability to work both independently and collaboratively

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

Desired:

• MS in a relevant field
• Current certification with CLIA-recognized accrediting agency (e.g., MT-ASCP, CLS-NCA, HTL-ASCP)
• Experience in a clinical molecular genetics testing laboratory
• Direct experience with Illumina (or other) next generation sequencing and genotyping procedures; and experience in the operating the instruments
• Knowledge of FDA regulations, including experience working with CGMP requirements
• Experience with auditing processes

How to Apply

Please navigate to the job announcement and click "Apply for this Job" at the bottom of the page. We will request a cover letter as well as your CV or resume. See job announcement here.

About Our Organization

The Department of Genome Sciences (GS) is part of the University of Washington School of Medicine and is comprised of laboratories addressing leading edge questions in medicine by developing and applying genetic, genomic and computational approaches that take advantage of genomic information. GS is making major contributions in the application of genome science to understand the fundamentals of biological and medical questions and to improve human health. GS is a collaborative department supported by very different academic disciplines. We work with a multitude of Program Investigators (PIs) in departments both on the UW campus as well as worldwide. The department has gone through significant expansion since its beginning in 2001 with grant awards of $57M in FY20.  The department has 62 training, teaching and research faculty and is among the top ranked programs in genetics/genomics/bioinformatics in the US.

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