Batch Record Reviewer II

Purpose:

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
• For Manufacturing Operations facility: Complete basic calculations for product yield and communicate batch release progress or delays to quality and materials management
• For Packaging Operations facility: 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: 

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

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.