Evotec

Senior Quality Assurance Specialist – QMS Operations

Evotec

full-time

Posted on:

Location Type: Hybrid

Location: Redmond • Washington • United States

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Salary

💰 $92,400 - $126,500 per year

Job Level

Senior

About the role

  • Review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.
  • 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 (including but not limited to SME for QMS processes and individual records).
  • 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 5 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
  • flexible work
  • 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
eQMSDeviationsChange ControlCAPARisk AssessmentManagement ReviewComplaint InvestigationProduct Quality ReviewQMS processcGMP
Soft skills
collaborationcommunicationattention to detail