QA Senior Specialist - Site Based, Redmond, WA

Posted 4 Days Ago
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Redmond, WA, USA
In-Office
110K-126K Annually
Senior level
Biotech • Pharmaceutical
The Role
The QA Senior Specialist ensures compliance in cGMP operations, trains junior staff, reviews documents, leads audits, and manages quality compliance issues.
Summary Generated by Built In

Job Title: QA Senior Specialist 

                                                                                

Location: Redmond, WA (onsite)
Shifts: Days, Monday to Friday, with some flexibility

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 Senior Specialist 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 Senior Specialist works cross-functionally to ensure compliance in operations to cGMP expectations and company SOPs.  The QA Senior Specialist is responsible for increasingly complex records and tasks, as well as training of junior personnel. The responsibilities of the employee are based on the assigned QA organization as outlined below.

Responsibilities – QA Operations

  • Review executed Manufacturing processing Batch Records.

  • Lead compliance walkthroughs of Manufacturing and other assigned areas.  Monitor corrections as appropriate.

  • Lead the training of new or junior staff.

  • Partner with Manufacturing to ensure compliance in Manufacturing operations.

  • Triage Manufacturing events and support event investigations.

  • Review and approve Master Batch Records, Process Technical Design, and other related documents.

  • Support internal and client audits. Present as subject matter expert during audits.

  • Execute process performance and product quality monitoring programs.

  • Identify potential compliance issues.

  • Alert senior management of significant quality, compliance, supply, or safety risks.

Qualifications

  • Bachelor’s degree in biological or engineering science

  • Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.

  • Ability to collaborate and communicate cross-functionally.

  • Proven attention to detail

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. Site is a site based role.

  • 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.

Are You Still Curious?

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

Let your curiosity guide your career—#BeCurious and explore the endless possibilities at Just Evotec Biologics!

The base pay range for this position at commencement of employment is expected to be $110,000 to $126,400;  Base salary offered may vary depending on 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.

Skills Required

  • Bachelor's degree in biological or engineering science
  • Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
  • Proven attention to detail
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The Company
HQ: Hamburg
5,042 Employees

What We Do

Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients. Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing. We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI. We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.

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