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 release. Support weekly lot disposition meetings with QA, Manufacturing, and QC while reviewing deviations, OOS, and change control records to prevent product impact. 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 biotherapeutic products at Seattle and Redmond facilities, preparing the team for Process License Inspections and commercial readiness.
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)
- 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
- Order to Cash
- Procure to Pay
- Supply Chain
- Customers
- Suppliers
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.