Manufacturing Compliance Specialist 1 - Site Based, Redmond, WA
EvotecAbout the role
Job Title: Manufacturing Compliance Specialist I
Location: Redmond, WA, site based, some travel to Seattle, WA site as required.
Shifts: 40 hours per week, Monday to Friday, days.
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 Manufacturing Compliance Specialist I 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 Manufacturing Compliance Specialist I 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.
The Manufacturing Compliance Specialist is a crucial role within the Just-Evotec JPOD Manufacturing Site MSAT team responsible for leading deviation investigations and managing Corrective and Preventive Actions (CAPAs) to maintain the highest levels of product quality and regulatory compliance.
What You’ll Do:
Improve the technical capabilities and quality practices within the department
Coordinate activities and resolve issues across the department, other groups, and/or projects
Respond to and/or resolve recurring technical or processing issues
Develop and implement novel approaches to solving non-routine technical problems
Communicate information effectively through updates, reports, and summaries
Lead improvements in processes and methods that reinforce cGMP within the department and/or across the site
Participate directly in internal, external, and global health authority audits/inspections
Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems
Conduct investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills
Provide training and guidance on the staff to meet the goals of the department
When appropriate, assist in providing leadership on project teams
Represent the department as the SME and lead multi-disciplinary teams or committees
Provide routine updates on progress, status, and issues associated with campaigns/projects
Provide support and/or direction to junior staff when necessary
Exercise sound judgment when making decisions
Make critical decisions in collaboration with key stakeholders
Demonstrate accountability for personal, departmental, and organizational initiatives
Who You Are:
BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engine
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