QA Specialist - QMS Site , Redmond, WA

Redmond, WA

Department:
Quality

Reports To:

Senior Manager, QA QMS/QAD

Shifts:

Monday to Friday. 8 hrs. Usually 08:00-16:00

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!

We’re looking for a passionate and curious Quality Specialist, 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 Quality Specialist, 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.

• Assess and approve all quality events in 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.
• Provides communication as to the status of deliverables to customers, management, and stakeholders.
• Deliver training for QMS process or system changes.
• Provide QA QMS in supporting internal and external client audits and regulatory inspections.
• Review and approve effectiveness checks 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.
• Execute process performance and product quality monitoring programs.
• Identify potential compliance issues.
• Alert senior management of significant quality, compliance, supply, or safety risks.

• Experience in helping to maintain a Quality infrastructure in a fast-paced growing company.
• Understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
• Experience in laboratory testing such as: SEC UHPLC, Potency and Residual Protein (ELISA), Osmolality, Solo VPE, Capillary Electrophoresis (SDS/rCE-SDS), Assay (icIEF),
• Experience in release testing, stability testing, equipment qualification, and method qualification
• Experience in tools, concepts, and methodologies of QA
• Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
• Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams.
• 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

• 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. This roles will be site based in Redmond, WA.
• Inclusive Culture :
  We’re committed to building a diverse and inclusive environment where everyone’s voice…