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Batch Record Reviewer II

Employer
AbbVie
Location
Lake County, Illinois
Start date
Feb 13, 2024

Job Details

Overview
This role will support several production buildings as part of the Site Operations Compliance team. The individual will engage with several production staff in-person at multiple buildings across the North Chicago site to deliver on key business deliverables and batch record improvement efforts. 

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 

  • 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.
  • Strong 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.


Company

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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