Senior QA Specialist, Supplier Quality
Evotec
Senior QA Specialist, Supplier Quality
Evotec
full-time
Posted on:
Location Type: Hybrid
Location: Redmond • Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $92,400 - $126,500 per year
Job Level
Senior
About the role
- Conduct supplier and material onboarding activities in accordance with approved procedures
- Conduct supplier onboarding audits and routine performance monitoring audits
- Conduct internal GMP Supplier Quality events (e.g., complaints, deviations, CAPAs) with escalation of critical issues affecting patient safety, product quality, or supply
- Assess supplier change notifications and initiate/process any follow-up actions necessary to determine impact and ensure compliance
- Negotiate and maintain quality agreements with service and material suppliers
- Conduct routine qualification of service and material suppliers
- Create, update and obsolete material specifications as needed
- Maintain supplier and material onboarding and performance documentation file
- Assess change controls for impact to supplier quality management
- Participate in raw material risk assessments
- Conduct investigations of supplier-related quality issues and root causes
- Other tasks as determined by management
Requirements
- Bachelor’s degree with 6+ years in Quality and 8+ years in the biotech industry
- Experience in Supplier Quality Management processes and methodologies
- Knowledge of biologics and pharmaceutical regulations, risk management, and science-based decision-making
- Project management experience
- Proficiency in Microsoft Office and electronic quality management systems (e.g., Veeva QualityDocs, eQMS)
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Supplier Quality ManagementGMPCAPARisk ManagementProject ManagementChange ControlRoot Cause AnalysisMaterial SpecificationsQuality AuditsPerformance Monitoring
Soft skills
NegotiationCommunicationProblem SolvingAttention to DetailOrganizational Skills
