Quality Assurance Associate I-II

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Cures Start Here.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network.

Careers Start Here.
The Cellular Processing Facility is a cGMP manufacturing facility that produces cell products utilized in early phase clinical research protocols. All products manufactured by the Cellular Processing Facility must meet required Food and Drug Administration (FDA) regulations for use in human clinical studies.

The Quality Assurance Associate I/II is responsible for supporting the receipt, processing, and release of the cellular therapy products manufactured in the Cellular Production Facility (CPF).
    * Review executed batch records for media and solution preparation.
    * Review executed manufacturing process batch records.
    * Review and release GMP raw materials.
    * Review and approve master batch records for media and solution preparation.
    * Perform document control functions including issuance of manufacturing batch records, logbooks, etc.
    * Perform quality system administration activities including deviation and CAPA number issuance, copying, scanning, and archival.
    * Assist in quality/compliance improvement projects.
    * Participate in scanning and archival of completed GMP documentation.

Associate's Degree or higher in a biological science and/or a minimum of two years of experience in a GMP environment.
    * Experience and understanding of cGMP requirements is required.
    * Experience writing or revising standard operating procedures and batch records.
    * Good organizational skills, attention to detail, and the ability to multi-task required.
    * Ability to interact constructively with peers and support groups.
    * Excellent written, verbal communication, and interpersonal skills.
    * Proficient in MS Office applications (Outlook, Word, Excel, PowerPoint).

Pay, Benefits, and Work Schedule
    * Full time position.
    * Evening and/or weekend work may be required.

To apply for this position, please CLICK HERE

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