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QA Shop Floor Specialist

2 months ago

Bothell, United States American Cybersystems Full time

As a QA Shop Floor Specialist, you will: 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 Project 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. 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. Education and Experience: Bachelor's degree in relevant science or engineering discipline is preferred. A minimum of associate 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 are 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. • Strong computer skills with Word and Excel and other electronic manufacturing systems. Qualified candidates should APPLY NOW for immediate consideration Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you Sara Almas Team Recruitment [Sara.Almas@innovasolutions.com]{target="_blank" rel="noopener"} PAY RANGE AND BENEFITS: Pay range: $40 -$ 43.33 Per To view the full job description,