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CLINICAL LABORATORY QUALITY ASSURANCE SPECIALIST, RESEARCH SCIENTIST / ENGINEER 3

University of Washington


Location:
Seattle, WA 98104
Date:
09/15/2020
2020-09-152021-01-30
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Job Details

CLINICAL LABORATORY QUALITY ASSURANCE SPECIALIST, RESEARCH SCIENTIST / ENGINEER 3

Req #: 182563
Department: GENOME SCIENCES
Job Location: Health Sciences Center,  Seattle Campus
Posting Date: 11/30/2020 
Closing Info: Open Until Filled 
Salary:

Salary and benefits are competitive. Salary is commensurate with qualifications and experience.  

Shift: First Shift 
Notes: The University of Washington is following physical distancing directives from state and local governments as part of the collective effort to combat the spread of COVID-19.  Click here for updates

Onsite work in the interim will vary for units and for specific positions and will be discussed with candidates during the interview process.
 

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. 

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.

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 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

As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here.

Application Process:

The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process.  These may include Work Authorization, Cover Letter and/or others.  Any assessments that you need to complete will appear on your screen as soon as you select Apply to this position. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your My Jobs page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.


Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.

Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.

The University of Washington is a leader in environmental stewardship & sustainability, and committed to becoming climate neutral.

The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu.


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