Fda Inspector Jobs in Bothell, WA (NOW HIRING)

Ensure compliance with FDA, EU GMP, and ICH regulations * Manage and mentor a team of validation ... Support audits and regulatory inspections Required Qualifications: * 15+ years of validation ...

Ensure compliance with cGMP, FDA regulations (including 21 CFR Part 11), and Evotec IT & Data ... Provide IT accountability for regulatory inspections, audits, and remediation activities related to ...

Ensure compliance with cGMP, FDA regulations (including 21 CFR Part 11), and Evotec IT & Data ... Provide IT accountability for regulatory inspections, audits, and remediation activities related to ...

Ensure compliance with cGMP, FDA regulations (including 21 CFR Part 11), and Evotec IT & Data ... Provide IT accountability for regulatory inspections, audits, and remediation activities related to ...

Ensure compliance with cGMP, FDA regulations (including 21 CFR Part 11), and Evotec IT & Data ... Provide IT accountability for regulatory inspections, audits, and remediation activities related to ...

... inspections. * Ensure clinical trials are conducted in compliance with protocols, Good Clinical Practice (GCP), ICH guidelines, SOPs, and regulatory standards (FDA/DEA). * Review and manage ...

Ensure cases are processed within required timelines and maintain compliance with FDA, EMA, ICH ... Compliance, Quality, & Inspection Readiness * Maintain continuous inspection readiness across all ...

Ensure alignment with FDA and NMPA regulatory requirements Data Analysis & Interpretation * Analyze ... Support audits and inspections * Collaborate with internal teams and external partners ...

... GMP), FDA and ICH guidance, EU Annex 1, biosafety standards, and radiation safety requirements ... Serve as the subject matter expert (SME) for regulatory audits and internal inspections focused on ...

Maintain GxP-regulated systems in compliance with FDA 21 CFR Part 11 and data integrity requirements. * Partner with Finance, Legal, and Quality during regulatory audits and inspections.

Ensure alignment with FDA QSR (21 CFR 820) and ISO 13485 * Review validation protocols, reports, and technical documentation * Partner with QA to support inspections and audits * Ensure proper risk ...

... GMP), FDA and ICH guidance, EU Annex 1, biosafety standards, and radiation safety requirements ... Serve as the subject matter expert (SME) for regulatory audits and internal inspections focused on ...

Ensure alignment with FDA and NMPA regulatory requirements Data Analysis & Interpretation * Analyze ... Support audits and inspections * Collaborate with internal teams and external partners ...

... and FDA guidance. This role will operate as an individual contributor and is responsible for ... Support internal and external audits, inspections, and regulatory inquiries related to statistical ...

Ensure alignment with FDA QSR (21 CFR 820) and ISO 13485 * Review validation protocols, reports, and technical documentation * Partner with QA to support inspections and audits * Ensure proper risk ...

... inspections, assist with site planning and interaction with customers and contractors as needed to insure preparation of the site to OEM specifications. * Completion of all necessary state and FDA ...

The laboratory is regulated by the Food and Drug Administration (FDA) cGTP/cGMP standards ... inspections, etc. * Review Sponsor-specific project source documentation and leverage technical ...

The laboratory is regulated by the Food and Drug Administration (FDA) cGTP/cGMP standards ... inspections, etc. * Review Sponsor-specific project source documentation and leverage technical ...

... inspections, assist with site planning and interaction with customers and contractors as needed to insure preparation of the site to OEM specifications. * Completion of all necessary state and FDA ...

... inspections, assist with site planning and interaction with customers and contractors as needed to insure preparation of the site to OEM specifications. * Completion of all necessary state and FDA ...