Quality Assurance Operations Specialist

15 hours ago

Bothell, Washington, United States Omni Inclusive Full time
Job Title:

Senior Specialist, Quality Assurance

Job Summary:

The Senior Specialist, Quality Assurance position 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.

Key Responsibilities:
  • Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date.
  • Leads/facilitates 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.
  • Partners with stakeholders to ensure smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure.
  • Uses both soft-skills and technical skills to drive the deviation and CAPA processes, including good teamwork, collaboration, and communication skills with all internal and external customers.
  • Participates on GEMBAs or process improvement projects to identify failure modes and seek further understanding of the deviations when needed.
  • Reviews deviation reports for good technical writing skills and actively coaches and mentors' investigators through the review and approval processes.
Requirements:
  • Bachelor's degree in a relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.
  • 5-8 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.
  • 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.
Working Conditions:

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.

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. Will be required to wear personal protective equipment (PPE) and other clean room garments daily.

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