About this role
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 batch
Ensure 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 requirements Minimum High School graduate2+ years of overall experience in Manufacturing, Quality or EngineeringKnowledge of GMP regulations and standards affecting pharmaceutical productsGood analytical skills and attention to detailGood interpersonal relations / communications skillsGood verbal and written communication skillsMust be available to work daily overtime, including weekends, as neededPreferred
Bachelor's or Associate's degree highly desiredExperience in quality batch records or electronic batch records highly desirable Minimum 5 years of experience in a manufacturing/finishing environment is desired Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolutediscretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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