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Quality Assurance Specialist
Bothell, Washington(50% onsite)
Phone + Video
W2 only
Major duties and responsibilities:
Working cross-functionally with teams to provide change management guidance
Responsible for gathering site metrics including providing annual APQR change control data
Work with Sr. Manager of Change Management with providing site training
Draft and review site change management guidance documents and work practices
Administrate scheduled and ad-hoc change management governance meetings including scheduling, building agenda, and issuing meeting minutes
Facilitate the closure of change control records within the quality management system
Perform ad hoc duties as required in support of all of the Quality Systems at the Jump site including, but not limited to the following:
o Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit.
o Identify and implement continuous improvement opportunities for Quality Systems
o Facilitate cross-functional team meetings
o Process, author, and review QMS (Quality Management System) documents in the electronic document management system
Provide communication on the status of deliverables to customers, management and stakeholders.
Education:
Bachelor's degree or equivalent
Experience / Knowledge Desired:
A minimum of three (3) years' experience in a change management related role, preferably within a Quality Systems team
Experience in quality management system (change management, deviation, CAPA, and risk management) processes is preferred
Strong technical writing skill set and able to critically review documents while effectively inputting and expressing Quality principles.
Innovative, proactive, and resourceful; committed to quality and continuous improvement.
Ability to work effectively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.
Strong knowledge of cGMPs and regulatory requirements
Must be able to self-direct, multi-task, and clearly communicate to the manager of decisions outside of established processes and the ability to build a cross functional network.
Stellent IT LLC
