Quality Specialist Raw Material Disposition – Quality Raw Materials (GMP)
$87,000–$95,000 year
On-siteRedmond, Washington, United States
Job Summary
Compile lot release documentation for Raw Material disposition and ensure deliverables are received from key stakeholders prior to disposition. Support weekly lot disposition meetings with QA, Manufacturing, and QC, while reviewing deviations, OOS, and change control records to verify no impact to product. Lead process improvements within Raw Material Disposition and provide audit/inspection support as required. Alert management of significant quality, compliance, supply, and safety risks. Partner with QA peers to ensure consistency and efficiency across the department. This role supports GMP manufacturing activities for late-stage and commercial biologics at Seattle and Redmond facilities.
Required Qualifications
- Bachelor's degree in biological or engineering science
- Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
- Ability to collaborate and communicate cross-functionally
- Proven attention to detail
- Day Shift, Monday-Friday, Core Hours 8:00am-5:30pm
- Location: Redmond (Onsite)
- GMP focused
- Support GMP operations for late stage and commercial biologics manufacturing
- Supplier and material onboarding
- Audit, complaint, and disposition activities
- Compile lot release documentation for Raw Material disposition
- Ensure lot release deliverables are received from key stakeholders prior to Raw Material disposition
- Support weekly lot disposition meeting with QA, Manufacturing, QC, etc.
- Review Deviations, OOS, and Change control records to ensure no impact to Product
- Lead process improvements within Raw Material Disposition
- Audit/inspection support for Raw Material Disposition as required
- Partner with other QA peers to ensure consistency and efficiency within the QA department
- Alert management of significant quality, compliance, supply, and safety risks
- Ensure compliance of all suppliers and raw materials dispositioned in support of our GMP manufacturing operations at the Seattle and Redmond, WA GMP facilities
Desired Qualifications
- Curiosity
- Scientifically sharp
- Operationally disciplined
- Think creatively while executing flawlessly in a regulated environment
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