Batch Record Reviewer II (3rd Shift)

Role Summary

The Batch Record Reviewer II audits Manufacturing and/or Packaging batch records, performs transactions in inventory systems to release batches for further processing, and coordinates problem-solving activities including solution implementation. This role ensures batch records are complete, accurate, and compliant with GMP regulations, company policies, and applicable standards. The role may involve releasing batch records in electronic systems and interfacing with various departments and regulatory agencies. This is a 3rd shift position (7:00 pm–7:30 am) with a Sunday–Tuesday schedule and every other Saturday.

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

Qualifications

• Required: Minimum High School graduate; 2+ years of overall experience in Manufacturing, Quality or Engineering
• Preferred: Bachelor's or Associate's degree
• Preferred: 5 years experience in a Manufacturing and/or Finishing and/or Packaging environment
• Preferred: 2 years experience in Batch Record Release strongly preferred
• Required: Knowledge of GMP regulations and standards affecting pharmaceutical products
• Required: Good verbal and written communication skills
• Required: Demonstrated analytical skills and attention to detail
• Required: Good interpersonal relations/communications skills
• Required: Must be available to work daily overtime, including weekends, as needed

Education

• High school diploma or equivalent required; Bachelor's or Associate's degree preferred