Senior Quality Assurance Specialist

4 days ago


Bothell, Washington, United States Insight Global Full time

Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Insight Global. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our products and services.

Key Responsibilities

  • Author, review, and approve SOPs and other controlled documents
  • Manage change controls and ensure proper documentation and implementation
  • Conduct internal audits and support external audits
  • Review and approve quality events such as deviations, CAPAs, and investigations
  • Ensure compliance with regulatory requirements and company standards
  • Participate in quality improvement initiatives and provide training on quality systems

Requirements

  • 5+ years of experience in Quality Control and/or Quality Assurance
  • Experience creating and writing standard operation procedures (SOP's), creating change controls, revising documents, and managing procedures
  • Experience authoring and owning deviations, CAPAs and Change Controls
  • Strong knowledge of GMP compliance
  • Background in biotech, pharma, or a similar industry
  • Associates degree in a relevant field with 2 years of experience or a bachelor's degree in a relevant field (in addition to 8+ years of relevant experience)

About Us

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters.



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