QA Specialist, Quality Management Systems (QMS)

Location: Redmond, WA
Department: Quality
Reports To: Senior Manager, QA

The Role: / your challenge, ...in our journey

We're looking for a passionate and curious QA Specialist, Quality Management Systems (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 QA Specialist, Quality Management Systems (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.

Position

This role is responsible for the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The role incumbent works both independently and 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.

QMS Operations

• Review and assess 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 inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders.
• Develop, review, and deliver 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 and review 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.

Qualifications:

• 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.

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 will be site based, Redmond, WA, will visit our Seattle, WA site.
• 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 $90,000 to $100,000; Base salary, exempt, 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 and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.