Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Batch Record Reviewer audits manufacturing and packaging batch records for accuracy and compliance to AbbVie policies and procedures and performs transactions in inventory systems to release the batch for further processing.
Responsibilities
Review and audit the data and records generated by Manufacturing and Packaging Operations in the processing of a material or product batchEnsure any batch record errors are corrected, all batch record components are present, and exception documents are referenced and approvedEnsure all in-process and release testing is complete and all Quality holds are releasedInterface with various electronic databases/systems to interpret data pertinent for release to specific countriesEnsure batch records are retained and filed securelyEnsure Quality goals are met, and all practices and procedures comply with Company policies and applicable regulationsInteract with other AbbVie departments, external customers, and regulatory agenciesMay release batch records in electronic systems according to global, local, customer and regulatory requirementsQualifications
Ability to carry and lift boxes weighing up to 50 lbs. Ability to walk, lift, bend, squat, stoop, stretch, sit and stand for long periods of time.Ability to work with human and porcine raw materials and finished goods specicially defined functional areas.Ability to work varied schedule with some potential weekend, early morning or late evening hours, if needed.Ability to carryout detailed written or oral instructions.Ability to handle a wide variety of tasks under critical time constraints.Must be comfortable working in a lab, warehouse and manufacturing settings.Willing to work with potentially biohazardess materials, including cadaveric tissue.Computer proficiency and scheduling experience required; good writing skills required.
Additional Information
AbbVie is an equal opportunity employer and 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html