Quality Assurance Associate

Evotec•Seattle, WA

2d•$65,000 - $90,000•Hybrid

About The Position

At Just-Evotec, 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: 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. This 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. The responsibilities of the employee is based on the assigned QA organization as outlined below.

Requirements

Bachelor's Degree biological sciences, chemistry, biochemistry, engineering, or related life science field and 1 year of relevant quality experience OR Associate’s degree and 3 years of relevant quality experience OR High school diploma / GED and 6 years of relevant quality experience.
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.
Provide input on communication as to the status of deliverables to customers, management, and stakeholders.
Assist with developing 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 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.
Lifecycle management of the stability program for clinical and commercial products
Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones.
Support the design of stability protocols to ensure that they are aligned with program strategy and regulatory requirements.
Ensure that stability studies are executed according to protocol.
Review, verification, disposition, and archival of stability study data for assigned programs.
Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution.
Interpretate stability results to support expiry, trending, and conditions of products.
Support product stability related content in regulatory submission, including responses to questions and post-marketing.

Benefits

Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life (hybrid model).
Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
A Place for Big Ideas: We don’t just talk about thinking outside the box, we throw the box away. If you’ve got ideas, we want to hear them.
Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

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