Quality Assurance Specialist

Job Summary

Providing quality assurance support to the Product Quality organization, the full-time remote Quality Assurance Specialist will collaborate with various functional areas to manage and approve product quality records, execute transactions in GMP systems, and support audits and continuous improvement initiatives.

Key responsibilities

• Provide QA Systems expertise and support to the Product Quality organization, collaborating within a team environment
• Manage and approve QA documentation for clinical and commercial products, including protocols, reports, and specifications
• Support audits, inspections, and continuous improvement initiatives to enhance quality systems efficiencies

Required qualifications

• Doctorate degree, or Master's degree with 2 years of relevant experience, or Bachelor's degree with 4 years of relevant experience, or Associate's degree with 8 years of relevant experience, or High school diploma/GED with 10 years of relevant experience
• Understanding of pharmaceutical sciences, quality, compliance, and regulatory requirements related to biologics and/or synthetics manufacturing
• Experience using VEEVA, Trackwise, and other quality systems
• Quality Assurance experience in reviewing and approving cGMP documentation
• Strong investigation skills related to deviations and CAPAs