QA Specialist IV - (Winston-Salem, NC)

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. Principal Duties and Responsibilities: Work with CMOs for review of batch records and release of production lots. Scan and upload copies of all approved batch records and CoAs to designated server. Maintain record of communication with CMOs for all quality related issues. Work with CMO to maintain a record (inventory) of all retention samples and stability lots. Hold periodic inventory reconciliation reviews with CMOs. Review and approve all changes to direct contact manufacturing materials, material testing, production procedures, or manufacturing processes prior to implementation of changes as required by Quality Agreement.