Senior Quality Assurance Specialist
4 days ago
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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