Quality Assurance Associate Ii
Current• Work closely with the relevant department(s) to ensure management of controlled documents (SOPs, Policies, MBRs, material specifications) are documented appropriately in compliance with regulatory requirements.• Oversee execution of CAPA program and perform efficacy check in a timely manner to confirm corrective actions are implemented appropriately to resolve identified root cause.• Oversee Vendor Assessment Program for critical GMP materials suppliers and service vendors and coordinates audits of Vendor’s Quality Management System to evaluate and qualify them. • Support subject matter experts in drafting the non-conformance investigation report, review it for completeness and accuracy and advise on potential corrective actions based on the root cause. • Perform a risk assessment to evaluate equipment and process quality impact assessments and document them appropriately using Quality Risk Management tools (FMEA and PHA). • Quality review of GMP study protocols, amendments, experimental data, and study reports ensuring completeness, compliance with specifications, internal and external regulations, and good documentation practices.
