Quality Senior Specialist, Raw Material Disposition - Site Based, Redmond and Seattle, WA
About The Position
We are seeking a GMP focused Quality Senior Specialist Raw Material Disposition to support QC operations for late stage and commercial biologics manufacturing. In this role, you will be a key contributor to ensuring the quality, consistency, and regulatory compliance of raw materials across our Seattle and Redmond GMP facilities. You will play a critical role in supplier and material onboarding, audit, complaint, and disposition activities in accordance with approved procedures—all essential to our path toward commercialization. This is a role for someone who is both scientifically sharp and operationally disciplined, who can think creatively while executing flawlessly in a regulated environment. The Quality Senior Specialist Raw Material Disposition will ensure compliance of all suppliers and raw materials dispositioned in support of our GMP manufacturing operations at the Seattle and Redmond, WA GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.
Requirements
- 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
Responsibilities
- Compile lot release documentation for Product and Raw Material disposition.
- Ensure lot release deliverables are received from key stakeholders prior to Product and Raw Material disposition.
- Facilitate 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 Lot and Raw Material Disposition.
- Audit/inspection support for Lot and Raw Material Disposition as required.
- Partners with other QA peers to ensure consistency and efficiency within the QA department.
- Alert senior management of significant quality, compliance, supply, and safety risks.
Benefits
- Medical
- Dental
- Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- generous paid time off
- paid holiday
- wellness and transportation benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
