QA Specialist - Site Based, Redmond, WA

Evotec•Redmond, WA

1d•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 Specialist role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The role incumbent works both independently and collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures. The responsibilities of the employee is based on the assigned QA organization as outlined below.

Requirements

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

Responsibilities

Review executed Manufacturing Batch Records
Execute compliance walkthrough of the Manufacturing floor and other assigned areas.
Participate in 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 and other supporting documents.
Support internal and client audits.
Execute process performance and product quality monitoring programs.
Alert senior management of significant quality, compliance, supply, and safety risks.