AbbVie Batch Record Reviewer II audits manufacturing and packaging batch records and coordinates problem-solving activities. Ensures compliance with GMP regulations and company policies.
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
Minimum High School graduate; Bachelor's or Associate's degree desired
Qualification
High School graduate minimumAvailability to work daily overtime
Required
High School graduate minimum; Bachelor's or Associate's degree desired
2+ years overall experience in Manufacturing, Quality or Engineering
Minimum 5 years experience in Manufacturing and/or Finishing and/or Packaging environment 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
Availability to work daily overtime, including weekends, as needed
