Product Review Coordinator II

The Batch Record Reviewer audits manufacturing and packaging batch records for accuracy and compliance to AbbVie policies and procedures and performs transactions in inventory systems to release the batch for further processing.

Responsibilities

• Review and audit the data and records generated by Manufacturing and Packaging Operations in the processing of a material or product batch
• Ensure any batch record errors are corrected, all batch record components are present, and exception documents are referenced and approved
• Ensure all in-process and release testing is complete and all Quality holds are released
• Interface with various electronic databases/systems to interpret data pertinent for release to specific countries
• Ensure batch records are retained and filed securely
• Ensure Quality goals are met and all practices and procedures comply with Company policies and applicable regulations
• Interact with other AbbVie departments, external customers, and regulatory agencies
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  May release batch records in electronic systems according to global, local, customer, and regulatory requirements