IT Compliance Engineer

Job Summary

Working full-time in Bothell, WA, the IT Compliance Engineer will lead compliance-related activities for GxP electronic systems and applications, partnering with cross-functional teams to ensure regulatory adherence and quality system management.

Key Responsibilities:

• Manage IT metrics reporting linked to regulatory compliance and Quality Events
• Perform investigations and root cause analyses for Quality Event deviations related to IT systems
• Author and review Quality Systems records, including Deviations, CAPAs, and SOPs

Required Qualifications:

• Bachelor's degree in life sciences, engineering, or technology, or 5 years of equivalent experience in biotechnology or pharmaceuticals
• 2+ years of experience with Quality Systems activities related to electronic records and signatures
• Strong knowledge of global Health Authority regulations and guidelines related to computerized systems
• Experience with various computerized systems such as MES, ERP, and QMS
• Understanding of ALCOA+ principles of data integrity