Quality Specialist Role at Evotec | Life Science Graduates can Apply
Evotec is seeking a Quality Specialist Job for its Redmond or Seattle, Washington, sites. This Life Science Job is ideal for candidates with a Bachelor’s degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, Biotechnology, or related scientific fields. The role focuses on environmental monitoring, implementing contamination control strategies, and driving continuous improvement initiatives within GMP-regulated biomanufacturing environments.
- Job Position: Quality Specialist – Contamination Control
- Location: Redmond, WA or Seattle, WA
- Job Type: Full-time, Site-based
- Job ID: 13019
About the Company
At Evotec, we provide cutting-edge Life Science Job opportunities in pharmaceuticals and biotech innovation. The company focuses on biologics and biotechnology solutions, pushing the boundaries of what’s possible in drug development and manufacturing. Evotec values continuous learning, inclusivity, and innovative thinking, providing employees opportunities to grow and contribute to life-changing scientific breakthroughs.
Job Description
As a Quality Specialist – Contamination Control, you will oversee contamination control and environmental monitoring programs, ensuring compliance with GMP regulations and company standards. This role involves:
- Monitoring air, surfaces, and personnel in cleanroom environments.
- Implementing contamination control strategies and continuous improvement initiatives.
- Performing risk assessments and identifying critical control points for microorganisms, endotoxins, pyrogens, and particles.
- Collaborating with cross-functional teams, including Manufacturing, Quality Control, Facilities, and MSAT.
- Supporting CAPA investigations, process validation, and facility/equipment qualification projects.
- Ensuring compliance with FDA, EMA, EU GMP Annex 1, and other regulatory requirements.
- Preparing and reviewing SOPs, protocols, reports, and change controls.
Key Responsibilities
- Environmental Monitoring & Trending:
- Develop and distribute environmental monitoring trend reports.
- Analyze data using statistical tools to identify contamination risks.
- Review air, surface, and personnel monitoring data and implement trending rules.
- Contamination Control Strategy (CCS) Implementation:
- Support the development and implementation of site-level contamination control strategies.
- Conduct risk assessments and identify critical control points.
- Monitor CCS effectiveness and recommend improvements.
- Continuous Improvement & Quality Systems:
- Lead initiatives related to contamination control and quality systems.
- Participate in CAPA investigations and root cause analysis.
- Support validation projects and provide training to personnel.
- Regulatory Compliance & Documentation:
- Ensure compliance with cGMP, FDA, EMA, and other regulatory guidelines.
- Maintain accurate documentation and records in line with data integrity requirements.
- Support audits and inspections with technical expertise.
Educational Qualifications
Bachelor’s degree in Microbiology, Biology, Biotechnology, or related field.
Experience and Skills
- 2+ years of experience in pharmaceutical, biotechnology, or medical device manufacturing.
- Expertise in environmental monitoring, contamination control, cleanroom operations, and aseptic processing.
- Knowledge of GMP regulations (EU GMP Annex 1, FDA, ICH guidelines).
- Experience with data analysis, statistical methods, and software (Excel, Minitab, LIMS, Veeva, SAP).
- Strong analytical thinking, project management, and communication skills.
Benefits:
- Competitive base pay: $83k – $86,250 + discretionary annual bonus
- Medical, Dental, Vision, Short-term & Long-term Disability
- Company-paid basic life insurance, 401k match
- Paid time off, holidays, wellness, and transportation benefits
- Flexible work environment and growth opportunities
