QA Associate - Quality Assurance - Site Based, Swing Shifts - Starting 12noon.

Evotec•Redmond, WA

2d•Onsite

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 Associate 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. As a QA Associate at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

Requirements

Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, or related life science field.
Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
Strong attention to detail
Ability to collaborate and communicate cross-functionally.

Responsibilities

Review executed Manufacturing Batch Records.
Participate in compliance walkthrough of the Manufacturing floor and other assigned areas.
Partner with Manufacturing to ensure compliance in Manufacturing operations.
Review and approve Master Batch Records and other supporting documents.
Execute process performance and product quality monitoring programs.
Alert senior management of potential deviations or compliance risks.
Initiate and review 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.
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 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.
Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones.