Posted on: June 8, 2021
Industry: QA Testers
Job Number: JN -062021-65221
100% onsite in Bothell, WA 98021
Purpose and scope of position:
- The Quality Associate position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant. 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 perspective within a regulated cGMP environment.
- The primary focus of the QA Associate 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.
Required Competencies: Knowledge, Skills, and Abilities:
- 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.
- 2-3 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
- Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
- Hands-on experience with batch record review and product disposition is preferred.
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