QA Specialist, Site Based, Redmond, WA

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.

About the role

We’re looking for a passionate and curious QA Specialist, Quality Management Systems (QMS) to join our team. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. You'll execute day-to-day QA responsibilities for GMP manufacturing, build and enhance quality assurance systems, and work both independently and collaboratively with Manufacturing, Quality, and Facilities staff to ensure compliance with cGMPs and internal procedures.

Responsibilities

• Review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.
• Provide inputs and reviews on communication regarding the status of deliverables to customers, management, and stakeholders.
• Develop, review, and deliver training regarding QMS process or system changes.
• Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records).
• Monitor and review effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement.

Qualifications

• Bachelor’s degree in biological or engineering science.
• Minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
• Ability to collaborate and communicate cross-functionally.
• Proven attention to detail.

Benefits

• Growth Opportunities: Professional courses, mentorship, and new projects to support continuous learning and development.
• Flexible Work Environment: Site-based in Redmond, WA, with visits to our Seattle, WA site; flexible work options to help balance professional and personal life.
• Inclusive Culture: A diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: Opportunity to work on groundbreaking initiatives and cutting-edge technology.
• Comprehensive Benefits: Medical, Dental, and Vision coverage, 401k company match, flexible paid time off, paid holidays, wellness, and transportation benefits.
• Discretionary Annual Bonus: Additional total rewards including performance-based bonuses.

Pay

The base pay range for this position at commencement of employment is expected to be $90,000 to $100,000. Base salary may vary depending on skills, experience, and competitive market value.