Job Description

We are seeking a Senior Quality Specialist to support the assessment and revision of procedures and work instructions for one of the site integration projects. The ideal candidate will have experience working in a GMP environment, creating and writing SOPs, change controls, and document revision. The Senior Quality Specialist will review existing SOPs, identify any gaps, and drive to put those procedures through the change control process. This role will be fully remote once initial training is complete onsite in Bothell, WA.

Key Responsibilities:

 - Support the development and revision of procedures and work instructions

 - Assist with document changes in Veeva systems

 - Manage change controls and ensure proper documentation and implementation

 - Work cross functionally with the site Quality Systems team

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

· 3+ years of relevant experience

 · Quality Control experience

 · Experience creating and writing standard operation procedures (SOP's), creating change controls, revising documents, and managing procedures

 · Strong knowledge of GMP compliance

Background in biotech, pharma, or a similar industry Experience with Veeva Vault 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.