Quality Assurance Operations - Bothell - Omni Inclusive

    Omni Inclusive
    Omni Inclusive Bothell

    6 days ago

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    Description

    Senior Specialist, Quality Assurance

    Location: Bothell, WA 100% Onsite

    • 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system.
    • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
    • Experience with use of complex Root Cause Analysis (RCA) tools and methodologies, research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.

    Purpose and Scope of Position:

    The Quality Assurance (QA) Senior Specialist, Deviation Facilitator position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump) and is an individual contributor role responsible for leading/facilitating triages, deviation approvals, and CAPA records through the electronic quality record management system at the Juno Manufacturing Plant (Jump) located in Bothell, WA. This role focuses on deviation triage, initiation, and classification of events at the Bothell Manufacturing Plant (JuMP) in Bothell, WA.

    Qualification Requirements:

    • Bachelor's degree in relevant science or engineering discipline is preferred.
    • Minimum of Associates degree and/or equivalent combination of education and experience is required.

    Roles and Responsibilities:

    • Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date.
    • Leads/facilitate triage, deviation process, investigations (as applicable), and No Impact deviation closure of records, CAPA (Corrective and Preventative Action), change controls, process transfers, and other business drivers are supported in a compliant manner.
    • Immediately upon assignment of a deviation, partners with their investigation team/cross-functional team approve No Impact Deviations in a timely manner to support RFT.

    Working Conditions:

    • Frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
    • May Work in areas that may have strong magnets.
    • May work in areas with exposure to vapor phase liquid nitrogen and other chemicals.
    • Must be able to gown per requirements to enter manufacturing space.


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