QA Shop Floor Specialist - Bothell, United States - System One Holdings, LLC

Description

Job Title: QA Shop Floor Specialist

Location: Bothell, WA

Hours/Schedule: 9:00pm - 7:30am, Sun - Wed

Compensation: $ $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.