QA Specialist – Deviations & CAPAs
Evotec
full-time
Posted on:
Location Type: Hybrid
Location: Redmond • Washington • United States
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Salary
💰 $83,000 - $86,250 per year
About the role
- execution of day-to-day QA responsibilities for GMP manufacturing
- building and enhancing the quality assurance systems
- review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.)
- provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders
- develop, review, and deliver training regarding QMS process or system changes
- support QA QMS in internal and external client audits and regulatory inspections
- monitor and review effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement
- alert senior management of significant quality, compliance, supply, and safety risks
Requirements
- Bachelor’s degree in biological or engineering science
- Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
- Ability to collaborate and communicate cross-functionally
- Proven attention to detail.
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
- generous paid time off
- 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 & Tools
quality assuranceGMP manufacturingeQMSCAPARisk AssessmentChange ControlComplaint InvestigationProduct Quality ReviewQMS processmetrics analysis
Soft Skills
collaborationcommunicationattention to detail