Batch Record Reviewer II

AbbVie • North Chicago, IL

1d • Onsite

About The Position

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.

Requirements

• 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

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
• Complete basic calculations for product yield (Manufacturing Operations)
• Communicate batch release progress or delays to quality and materials management (Manufacturing Operations)
• Ensure all in-process and release testing is complete and all Quality holds are released (Packaging Operations)
• Release batch records in electronic systems according to global, local, customer, and regulatory requirements (Packaging Operations)
• 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

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• short-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED