Work with members of mv, r&d, qc, qa and other groups (manufacturing, validation, etc.) as necessary to generate validation and stability protocols for raw materials, process intermediates, and final product.
The primary responsibilities of the Specialist, Quality Assurance - Complaints include completion of customer complaint investigations partnering with Subject Matter Experts from various functional disciplines to identify root cause and appropriate corrective/preventative actions.
In this role, the selected candidate will plan and conduct Quality Assurance and Contamination Prevention audits at third party contract manufacturing sites and bulk distribution terminals to ensure compliance with guidelines.
The Quality Specialist IV has responsibility for GMP activities related to materials, production, product release, labeling, change control and post market monitoring activities for assigned RAI operating company. This individual will serve as the main quality contact between Contract Manufacturing Organizations (CMOs) and S&RA Quality Assurance group.