QA Senior Specialist - Site Based, Redmond, WA
About The Position
At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated. We’re looking for a passionate and curious QA Senior Specialist to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. The QA Senior Specialist works cross-functionally to ensure compliance in operations to cGMP expectations and company SOPs. The QA Senior Specialist is responsible for increasingly complex records and tasks, as well as training of junior personnel. The responsibilities of the employee are based on the assigned QA organization as outlined below.
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
- Review executed Manufacturing processing Batch Records.
- Lead compliance walkthroughs of Manufacturing and other assigned areas.
- Monitor corrections as appropriate.
- Lead the training of new or junior staff.
- Partner with Manufacturing to ensure compliance in Manufacturing operations.
- Triage Manufacturing events and support event investigations.
- Review and approve Master Batch Records, Process Technical Design, and other related documents.
- Support internal and client audits.
- Present as subject matter expert during audits.
- Execute process performance and product quality monitoring programs.
- Identify potential compliance issues.
- Alert senior management of significant quality, compliance, supply, or safety risks.
Benefits
- Medical
- Dental
- Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- 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
