Quality Specialist 3 - Compliance and Audits

- Bachelor's degree in a life science discipline. - 2+ years' experience in conducting internal audits, client audits, or Client quality agreements in a Quality Assurance role. - 2+ years' experience in leading and/or reviewing root cause analysis and CAPA for deviations in a Quality Assurance role

- Experience in a GxP CRO/CDMO/CTO or multi-client environment. - Experience with inspection readiness programs and regulatory responses. - Experience analyzing compliance metrics and quality trends. - Working knowledge of FDA 21 CFR Parts 58, 210, 211, Part 11, EU GMP requirements, and ICH Q9/Q10. - Broad quality systems experience across multiple QA disciplines. - Experience in conducting supplier audits - Demonstrate proven track record of effective communication with internal stakeholders and external clients. - Strong analytical, communication, organizational, and problem-solving skills. - Demonstrated ability to work independently, influence stakeholders, and foster a culture of quality and compliance.