*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.
3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Hands-on experience with batch record review and product disposition is preferred.
Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection auditing, QA reporting, and approval of GMP documentation.a
Strong computer skills with Word and Excel and other electronic manufacturing systems.
Detail oriented team player with effective planning, organization, time management and execution skills.
Proven experience working on teams where combined contribution, collaboration, and results were expected.
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Ability to work in a high paced team environment.
Strong written and verbal skills.
*ROLES AND RESPONSIBILITIES:
Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
Provide Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP.
Provides technical knowledge and guidance towards GMP compliance during triage/troubleshooting activities.
Review deviations, product non-conformities, and GMP investigations to ensure compliant resolution and adherence to current Good Manufacturing Practices (cGMPs).
Own, review, and approve deviations, including Deviation classification and completion of Impact Assessments, as applicable.
Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
Oversee manufacturing operations from patient material receipt to drug product pack out.
May support internal and external audits, including documenting observations.
Own and participate in review and approval for CAPAs.
Identify and facilitate continuous improvement projects.
Revise Standard operating Procedures as needed, and review/approve document revisions.
Drives right first time (RFT) by providing direct training, guidance, and problem solving to peers.
Provide training, coaching, and feedback for GMP guidance.
Continue support of continuous improvement culture and operational excellence methodologies.
Support change control initiatives as applicable.