AbbVie

Batch Record Reviewer II

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 26, 2020
Ref
2007793
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
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 , YouTube and LinkedIn .

  • 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 agenciesEnsure 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

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.