QA Shop Floor Specialist
Company: Aequor Technologies
Location: Bothell
Posted on: May 7, 2024
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Job Description:
**Schedule- 9:00pm - 7:30am, Sun - Wed**
**Top Skills:
Job Description: **Schedule- 9:00pm - 7:30am, Sun - Wed**
**Top Skills:
*Job Description:
The Quality Assurance Specialist position plays a key role in
supporting the cGMP quality operations for the Bothell
Manufacturing Plant (Jump). Primary Responsibilities include the
review of cGMP Controlled Documents such as SOPs, specifications,
completed batch records, material disposition, and manages
implementation of required changes to meet cGMP and internal
standards. This role directly supports Jump's release for infusion
(RFI) timeline from the date of manufacture and will support all
activities for routine clinical and commercial product release at
Jump with an emphasis on supporting Manufacturing with a Quality
on-the-floor presence within a regulated cGMP environment.
The primary focus of the QA Specialist role will be to support
routine clinical and commercial production to ensure consistent
compliance with regulatory and industry expectations. Assist the QA
department in maintaining the Quality focused culture at Jump by
ensuring documentation is complete, accurate and that batch records
are executed in accordance with approved and effective standard
operating procedures and specifications.
The QA Specialist primary role is on-the-floor and contributes with
off-the-floor projects and activities that are just as significant
as on-the-floor work.
*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.
*ROLES AND RESPONSIBILITIES:
Additional Job Requirements:
Keywords: Aequor Technologies, Shoreline , QA Shop Floor Specialist, Other , Bothell, Washington
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