Raw Materials Quality Senior Specialist - Site Based, Redmond & Seattle, WA
Evotec
July 01, 2026
On-site
Redmond, WA
Operations
What You’ll Do (GMP Heavy Responsibilities)
- Drive supplier and material onboarding and change management per approved procedures, industry standards, and regulatory requirements.
- Investigate internal supplier quality events (deviations, CAPAs); escalate critical issues impacting patient safety, product quality, or supply.
- Assess supplier change notifications and manage follow-up actions to determine impact and ensure compliance.
- Support supplier onboarding audits, qualification, and routine performance monitoring audits.
- Create, update, and obsolete material specifications and procedures.
- Initiate and assess change controls for supplier quality, process impact, and patient safety.
- Lead raw material risk assessments, including extractables/leachables assessment.
- Collaborate cross-functionally to assess raw materials and associated investigations.
- Support audit/inspection readiness and ensure response CAPAs are effective.
- Plan, coordinate, and continuously improve processes/systems for quality of released raw materials.
- Communicate deliverable status to customers, management, and stakeholders; participate in daily/weekly operational meetings.
Qualifications & Competencies (Requirements)
- BS in Chemistry (or related) + 5+ years GMP quality experience in biopharma/biotech.
- Materials science background; chemical compatibility and extractables/leachables.
- Strong cGMP/FDA/EMA knowledge; ICH/ISO and USP/EU/JP guidance.
- Experience supporting regulatory inspections/responses.
- Understanding of biotherapeutic process equipment/operations and analytics to qualify/release raw materials.
- Biologics regulatory requirements, risk management, investigation process, and science-based decision making.
- Ability to interpret/assess/communicate raw material impact on process data.
- Quality focus, attention to detail, time management; strong communication, data analysis, judgment, decision-making.
- Microsoft Office (Excel/Word/PowerPoint) and eQMS databases; adapt in fast-paced environment; manage multiple priorities; work independently and as part of a team.
Benefits / Application Instructions
- Apply today: “Let your curiosity guide your career—#BeCurious.” Base pay range: $92,400–$126,500; additional rewards include discretionary bonus, Medical/Dental/Vision, disability, life insurance, 401k match, paid time off/holidays, wellness and transportation benefits.
- Drive supplier and material onboarding and change management per approved procedures, industry standards, and regulatory requirements.
- Investigate internal supplier quality events (deviations, CAPAs); escalate critical issues impacting patient safety, product quality, or supply.
- Assess supplier change notifications and manage follow-up actions to determine impact and ensure compliance.
- Support supplier onboarding audits, qualification, and routine performance monitoring audits.
- Create, update, and obsolete material specifications and procedures.
- Initiate and assess change controls for supplier quality, process impact, and patient safety.
- Lead raw material risk assessments, including extractables/leachables assessment.
- Collaborate cross-functionally to assess raw materials and associated investigations.
- Support audit/inspection readiness and ensure response CAPAs are effective.
- Plan, coordinate, and continuously improve processes/systems for quality of released raw materials.
- Communicate deliverable status to customers, management, and stakeholders; participate in daily/weekly operational meetings.
Qualifications & Competencies (Requirements)
- BS in Chemistry (or related) + 5+ years GMP quality experience in biopharma/biotech.
- Materials science background; chemical compatibility and extractables/leachables.
- Strong cGMP/FDA/EMA knowledge; ICH/ISO and USP/EU/JP guidance.
- Experience supporting regulatory inspections/responses.
- Understanding of biotherapeutic process equipment/operations and analytics to qualify/release raw materials.
- Biologics regulatory requirements, risk management, investigation process, and science-based decision making.
- Ability to interpret/assess/communicate raw material impact on process data.
- Quality focus, attention to detail, time management; strong communication, data analysis, judgment, decision-making.
- Microsoft Office (Excel/Word/PowerPoint) and eQMS databases; adapt in fast-paced environment; manage multiple priorities; work independently and as part of a team.
Benefits / Application Instructions
- Apply today: “Let your curiosity guide your career—#BeCurious.” Base pay range: $92,400–$126,500; additional rewards include discretionary bonus, Medical/Dental/Vision, disability, life insurance, 401k match, paid time off/holidays, wellness and transportation benefits.