JustEvotec Biologics

QASpecialist,SiteBased,Redmond,WA

$90–90k Redmond, Washington, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“QA Specialist, Site Based, Redmond, WA at JustEvotec Biologics. Skills: Quality Management Systems (QMS), cGMP compliance, Cross-functional coordination, Vendor/stakeholder management, Operational metrics, Resource planning, Continuous improvement. Execution of day-to-day QA responsibilities for GMP manufacturing. Building and enhancing the quality assurance systems”

What You'll Achieve.

Assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements; Monitor and review effectiveness for QMS through trending, analysis, and report to top management and G-QMS on the performance of the KPIs; Identify opportunities for continuous improvement

Industry & Context.

Problems you'll solve

Solving complex problems; Finding creative solutions

What They're Looking For.

Must Have

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

What You'll Do.

Execution of day-to-day QA responsibilities for GMP manufacturing

Building and enhancing the quality assurance systems

Ensuring compliance with cGMPs and internal procedures

Review and assess all quality events of eQMS (Deviations

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 as to the status of deliverables to customers

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

and report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement

How You'll Work.

Team & Collaboration

Collaborate and communicate cross-functionally; Works both independently and collaboratively with Manufacturing, Quality and Facilities staff; Provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders; Support QA QMS in internal and external client audits and regulatory inspections

Communication Scope

Ability to collaborate and communicate cross-functionally; Provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders

Full Job Description

QA Specialist, Quality Management Systems (QMS) **Location:** Redmond, WA **Department:** Quality **Reports To:** Senior Manager, QA **About Us: this is who we are** 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. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? **#BeCureious** with us and see where your curiosity can take you! **The Role: / your challenge, …in our journey** We’re looking for a passionate and curious QA Specialist, Quality Management Systems (QMS) 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 Specialist, Quality Management Systems (QMS) 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. **Position** This 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. **QMS Operations** * Review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation

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