QA Senior Specialist - Site Based, Redmond, WA

Evotec•Redmond, WA

2d•$110,000 - $126,400•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. 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.