The Specialist, Quality Assurance is responsible for QA batch record review and disposition assuring that bulk and finished products batch record documentation complies with Abbvie policies, regulatory requirements and current Good Manufacturing Practices. The function ensures the plant products meet specifications and quality requirements. This will require interaction with other Quality Assurance, Production, Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports.

Responsibilities

• Audit API, Bulk and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
• Evaluate potential discrepancies detected in batch records and determine the need for a corrective action. Approve MES exceptions related to production support.
• Track/trend batch record discrepancies per procedural requirements and work with other departments to evaluate the discrepancies to establish necessary actions to reduce errors.
• Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements. Prepare Certificate of Analysis, Certificates of Compliance for API and/or finished Drug Product.
• Enter and verify batch information into the lot restriction management system. Assemble the batch record review package and label per the approved retention procedures.
• Support the annual product quality review process.
• Prepare reports related to Right the First Time, Release Cycle Time, Regulatory Audit requests and Product Quality Review. Revise procedures as required.
• Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch record status including discrepancies and/or issues that may impact batch release.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.