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QA Senior Specialist, Supplier Quality - Hybrid, Redmond, WA

QA Senior Specialist, Supplier Quality - Hybrid, Redmond, WA

Just Evotec BiologicsRedmond, WA, US
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QA Senior Specialist, Supplier Quality

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 encouragedit's celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? Be curious with us and see where your curiosity can take you!

We're looking for a passionate and curious QA Senior Specialist, Supplier Quality 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 Senior Specialist, Supplier Quality 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.

What You'll Do :

  • Conduct supplier and material onboarding activities in accordance with approved procedures
  • Conduct supplier onboarding audits and routine performance monitoring audits.
  • Conduct internal GMP Supplier Quality events (e.g., complaints, deviations, CAPAs) with escalation of critical issues affecting patient safety, product quality, or supply.
  • Assess supplier change notifications and initiate / process any follow-up actions necessary to determine impact and ensure compliance.
  • Negotiate and maintain quality agreements with service and material suppliers.
  • Conduct routine qualification of service and material suppliers.
  • Create, update and obsolete material specifications as needed.
  • Maintain supplier and material onboarding and performance documentation file.
  • Assess change controls for impact to supplier quality management.
  • Participate in raw material risk assessments.
  • Conduct investigations of supplier-related quality issues and root causes.
  • Other tasks as determined by management.
  • Travel expectation for on-site supplier audits and support of client audits and regulatory inspections at JEB sites.

Who You Are :

  • Bachelor's degree with 6+ years in Quality and 8+ years in the biotech industry.
  • Experience in Supplier Quality Management processes and methodologies.
  • Knowledge of biologics and pharmaceutical regulations, risk management, and science-based decision-making.
  • Project management experience.
  • Proficiency in Microsoft Office and electronic quality management systems (e.g., Veeva QualityDocs, eQMS).
  • Why Join Us :

  • 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 role will be either site based or we will consider hybrid - travel expectation for on-site supplier audits and support of client audits and regulatory inspections at JEB sites.
  • 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 boxwe throw the box away. If you've got ideas, we want to hear them.
  • Are You Still Curious?

    If you've read this far, then chances are you've got a curious mindjust like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.

    Let your curiosity guide your careerBe Curious and explore the endless possibilities at Just Evotec Biologics!

    The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; base salary offered may vary depending on the individual's skills, experience and competitive market value. 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.

    Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

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