Job Title : QA Shop Floor Specialist
Location : Bothell, WA
Hours/Schedule : 9:00pm - 7:30am, Sun - Wed
Compensation : $37.00 - $42.41/hr
Type: Contract, Potential for extension or conversion to permanent
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. Requirements 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. 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. . Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
