Vacancy caducado!
Responsibilities:
Review and audit the data and records generated by Manufacturing 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 as part of batch record review process. Communicate batch release progress or delays to quality and materials management
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
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
SAP and Maximo knowledge desired
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.
Vacancy caducado!