Job Information
Insight Global Senior Quality Assurance Specialist in Bothell, Washington
Job Description
Summary:
As a Senior Quality Assurance Specialist, the candidate will be responsible for authoring, reviewing, and approving SOPs and other controlled documents, managing change controls, and ensuring proper documentation and implementation. They will conduct internal audits, support external audits, and review and approve quality events such as deviations, CAPAs, and investigations. Additionally, the candidate will ensure compliance with regulatory requirements and company standards, participate in quality improvement initiatives, and provide training on quality systems. They will also play a crucial role in supporting an integration project, ensuring seamless quality assurance processes throughout the transition.
Key Responsibilities:
- Author, review, and approve SOPs and controlled documents.
- Manage change controls and ensure proper documentation and implementation.
- Conduct internal audits and support external audits.
- Review and approve quality events (deviations, CAPAs, investigations).
- Ensure compliance with regulatory requirements and company standards.
- Participate in quality improvement initiatives.
Support an integration project to ensure seamless quality assurance processes
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. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
8+ years of experience within 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) null
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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.