Just Evotec Biologics
biopharmaceutical/Pharmaceutical
QAAssociate
Neural analysis suggests this role is
optimal for Entry candidates.
“QA Associate at Just Evotec Biologics. Skills: QA Associate responsibilities for GMP manufacturing, cGMP compliance, Quality Management Systems (QMS) execution and monitoring, eQMS event initiation and review. Execution of day-to-day QA responsibilities for GMP manufacturing. Review executed Manufacturing Batch Records”
Industry & Context.
solving complex problems
Shifts: Days, Mon to Fri, 8 hour shifts, ending 16:00, with Ad-hoc days for business requirements.
What They're Looking For.
Must Have
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, attention to detail, Ability to collaborate and communicate cross-functionally
What You'll Do.
Execution of day-to-day QA responsibilities for GMP manufacturing
Review executed Manufacturing Batch Records
Participate in compliance walkthrough of the Manufacturing floor and other assigned areas
Review and approve Master Batch Records and other supporting documents
Execute process performance and product quality monitoring programs
Initiate and review all quality events of eQMS (Deviations
Complaint Investigation
Product Quality Review etc.)
Support QA QMS in internal and external client audits and regulatory inspections
Monitor 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
Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones
How You'll Work.
Team & Collaboration
Works collaboratively with Manufacturing, Quality and Facilities staff; Partner with Manufacturing to ensure compliance in Manufacturing operations; Act as the QA representative on cross-functional product teams
Communication Scope
Ability to collaborate and communicate cross-functionally
Full Job Description
**Job Title:** QA Associate **Location:** Redmond, WA (onsite) **Shifts:** Days, Mon to Fri, 8 hour shifts, ending 16:00, with Ad-hoc days for business requirements. **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 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. The QA Associate role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing. This role works collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures. **What You 'll Do:** * 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 regulator
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