1+ months


University of Washington
Seattle, WA 98104


Req #: 174206
Job Location: Other Location
Posting Date: 11/21/2019 
Closing Info: Open Until Filled 
Salary: Salary is commensurate with qualifications and experience.  
Shift: First Shift 
Notes: As a UW employee, you will enjoy generous benefits and work/life programs. 
For detailed information on Benefits for this position, click here.

As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world.

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 Institute of Translational Health Sciences (ITHS) is a $70M health research institute based at the University of Washington, with integrated partnerships with Fred Hutchinson Cancer Research Center and Seattle Childrens Hospital, and more than 20 other organizations engaged in health research in five states in the Pacific Northwest region.  The mission of ITHS is to accelerate the translation of scientific discoveries to the clinic and beyond to improve the health of people in our region today.  We develop critical resources to help innovators move their discoveries forward.  ITHS fosters innovative health research, sustains research resources, and provides education and career development programs.

The ITHS Gene and Cell Therapy Lab currently has an outstanding opportunity for a QA Scientist to support clinical trials and cellular products that are produced in the lab. Their support will primarily be in the areas of creating, filing and organizing the varying documents that are generated during the production of cell therapies.


Maintain the cGMP Document Management (documents, document changes, change controls, and training records) for the Gene and Cell Therapy Lab (GCTL):
  • Maintain document tracking system, issue and track document distribution, including storage of hard copy documents and scanning of documents for archival.
  • Process document revisions: review documents for format and grammar, compliance with existing documentation procedures, and perform minor edits.
  • Issue controlled documents, i. e. Batch Records, forms, Deviation Reports and Change Control records.
  • Establish and maintain training files for all personnel.

    Be trained on Quality Assurance review of documentation generated by the GCTL. As a back-up to the Quality Manager, release cellular products generated by the GCTL:
  • Review completed batch records and other documents for completeness and adherence to applicable SOPs.
  • Coordinate with staff to ensure necessary corrections are made and all deviations from SOPs are properly documented.
  • Disposition cellular products based on thorough review of executed batch records and QC data.

  • Bachelors Degree in Biological Science.
  • A minimum of three months of job-related experience.

  • Experience working with FDA cGMP regulations and guidelines

  • Employee must undergo blood borne pathogen and HIPPA Compliance training.
  • Employee must be willing to work a flexible schedule in a highly regulated environment.

    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 assessments 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.

  • 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 equal opportunity, affirmative action employer. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 / 206-543-6452 (tty) or dso@uw.edu.


    Posted: 2019-12-05 Expires: 2020-02-02

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    University of Washington
    Seattle, WA 98104
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