Quality Specialist - Contamination Control -Site based, Redmond, WA or Seattle, WA site.

Quality Specialist - Contamination Control

About Us: this is who we are

At Just Evotec Biologic, 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 Quality Specialist - Contamination Control 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 Quality Specialist - Contamination Control at Just Evotec Biologic, 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.

This role specializes in environmental monitoring, contamination control strategy implementation, and continuous improvement initiatives. This role is essential for maintaining manufacturing environments and ensuring compliance with GMP regulations in pharmaceutical/biotechnology operations.

What You’ll Do:

Environmental Monitoring & Trending

• Develop, author, and distribute comprehensive environmental monitoring trending reports on a monthly, quarterly, and annual basis

• Analyze environmental monitoring data using statistical tools and trending methodologies to identify adverse trends, seasonal variations, and potential contamination risks

• Review and evaluate viable air samples, non-viable particulate counts, surface monitoring, and personnel monitoring data

• Implement trending rules and investigate out-of-trend conditions in accordance with established protocols

• Utilize data visualization tools and software for effective trend analysis and reporting

Contamination Control Strategy (CCS) Implementation

• Support the development, implementation, and maintenance of site-level contamination control strategies in compliance with EU GMP Annex 1 and other regulatory guidelines

• Conduct risk assessments and identify critical control points for microorganisms, endotoxin/pyrogen, and particles

• Collaborate with cross-functional teams including Manufacturing, Quality Control, Facilities, and MSAT to ensure integrated contamination control approaches

• Monitor CCS effectiveness and recommend improvements based on performance data and regulatory updates

Continuous Improvement & Quality Systems

• Lead continuous improvement initiatives related to contamination control, environmental monitoring programs, and quality systems

• Participate in CAPA investigations and root cause analysis for contamination events and environmental monitoring deviations

• Support process validation activities, equipment qualification, and facility qualification projects

• Provide training and technical expertise to manufacturing personnel on contamination control procedures and environmental monitoring requirements

Regulatory Compliance & Documentation

• Ensure compliance with cGMP regulations, FDA, EMA, and other regulatory requirements

• Review and approve contamination control-related documents including SOPs, protocols, reports, and change controls

• Support regulatory inspections and audits by providing technical expertise and documentation

• Maintain accurate and complete records in accordance with data integrity requirements

Who You Are:

Education

• Bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, Biotechnology, or related scientific field

Experience

• Minimum 2 year plus of experience in pharmaceutical, biotechnology, or medical device manufacturing with specific focus on:

  • Environmental monitoring and contamination control in GMP-regulated environments

  • Cleanroom operations and aseptic processing

  • Quality systems and regulatory compliance

  • Data analysis, trending, and s