Quality Assurance Specialist
24 hours ago
Location: Bothell, WA
Schedule: Wed - Sat: 1:30pm -12:00am
Top Skills:- 3-5 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system.
- Demonstrate excellence in written and verbal communication.
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
The Quality Assurance (QA) Specialist plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant. This individual contributor role is responsible for leading/facilitating triages, deviation approvals, and CAPA records through the electronic quality record management system.
Qualification Requirements:- Education: 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.
- Experience: 3-5 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system.
- Experience in cGMPs and FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Minimum of 4 years working within quality systems managing deviations and CAPA.
- 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.
While performing the duties of this job, the employee is 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.
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