Cyprotex

QA Senior Specialist - Site Based, Redmond, WA - Swing Shifts from 12noon

Cyprotex Redmond, Washington, United States · $110K–$126K/yr

Biotechnology Research · 501-1,000 employees

Yesterday
qa Senior (5-10 yrs) Full-time United States
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About the role

The QA Senior Specialist is responsible for reviewing manufacturing batch records, leading compliance walkthroughs, and supporting event investigations. They also provide subject matter expertise during audits and ensure manufacturing operations adhere to cGMP standards.

What they look for

Quality Assurance Batch Record Review Compliance Monitoring Staff Training Event Investigation Master Batch Record Approval Process Technical Design Audit Support Subject Matter Expertise Process Performance Monitoring Product Quality Monitoring Risk Assessment cGMP Biopharmaceutical Manufacturing Cross-functional Collaboration Attention To Detail

Requirements

Candidates must hold a Bachelor's degree in biological or engineering science and possess at least 5 years of relevant experience in a biopharmaceutical or pharmaceutical cGMP environment. Strong communication skills and proven attention to detail are essential for this role.

Benefits

Medical insurance Dental insurance Vision insurance Short-term disability Long-term disability Company paid basic life insurance 401k company match Flexible work Paid time off Paid holiday Wellness benefits Transportation benefits Discretionary annual bonus

Full description

Job Title: QA Senior Specialist 

Location: Redmond, WA

Department: Quality

Reports To: Quality Manager Shifts: Swing Shifts, Wed till Sat, 12noon till 22:00pm

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.

As a QA Senior Specialist 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:

·       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.

Who You Are:

·       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.

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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