The Batch Record Reviewer II audits Manufacturing and/or Packaging batch records, performs transactions in inventory systems to release batches for further processing (Packaging) and coordinates problem-solving activities, including solution implementation.

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 Quality goals are met, and all practices and procedures comply with Company policies and applicable regulations
• Develop and implement process improvements for improved compliance and/or efficiencies
• This role will also (depending on facility type);
  Manufacturing Operations:
  Complete basic calculations for product yield.
  Communicate batch release progress or delays to quality and materials management
• Packaging Operations:
  Ensure all in-process and release testing is complete and all Quality holds are released
• Release batch records in electronic systems according to global, local, customer, and regulatory requirements
• Interface with various electronic databases/systems to interpret data pertinent for release to specific countries
• Interact with other AbbVie departments, external customers, and regulatory agencies
  Ensure batch records are retained and filed securely
• Lead problem-solving activities and coordinate the implementation of identified solutions