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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge in our journey

Were looking for a passionate and curious Quality Specialist - Contamination Control to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll 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 youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its 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 Youll 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

• Bachelors 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 statistical methods

Technical Skills

• Proficiency in environmental monitoring techniques including viable/non-viable air sampling surface sampling and personnel monitoring

• Experience with data analysis software (Excel Minitab statistical packages) and trending methodologies

• Knowledge of GMP regulations particularly EU GMP Annex 1 FDA guidance and ICH guidelines

• Familiarity with electronic management systems (Veeva SAP) and LIMS systems

• Understanding of contamination control strategies risk management principles (ICH Q9) and quality systems

Key Competencies

• Analytical thinking and problem-solving abilities for trend analysis and investigation

• Strong communication skills for report writing training delivery and cross-functional collaboration

• Attention to detail and accuracy in data analysis and documentation

• Project management skills for leading improvement initiatives and validation activities

• Regulatory mindset with understanding of compliance requirements and industry standards

Physical Requirements

• Ability to work in controlled environments including cleanrooms with appropriate gowning

• Regular computer work for data analysis and report generation

• Occasional travel for training conferences or multi-site support

• Standard laboratory safety requirements and PPE usage

Preferred Qualifications

• Experience with sterilization processes bioburden testing and sterility assurance programs

• Knowledge of HACCP FMEA and other risk assessment methodologies

• Previous experience in biologics or monoclonal antibody manufacturing

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. Site based either Redmond or Seattle.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll 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 dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologic.

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

The base pay range for this position at commencement of employment is expected to be $83k to $86250; Base salary offered may vary depending on the individuals 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.