About this role
The Batch Record Reviewer II audits Manufacturing and/or Packaging batch records, performs transactions in inventory systems to release batches for further processing (Packaging) and coordinates problem-solving activities, including solution implementation.
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 Quality goals are met, and all practices and procedures comply with Company policies and applicable regulationsDevelop and implement process improvements for improved compliance and/or efficienciesThis 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 managementPackaging Operations:
Ensure all in-process and release testing is complete and all Quality holds are releasedRelease batch records in electronic systems according to global, local, customer, and regulatory requirementsInterface with various electronic databases/systems to interpret data pertinent for release to specific countriesInteract with other AbbVie departments, external customers, and regulatory agencies
Ensure batch records are retained and filed securelyLead problem-solving activities and coordinate the implementation of identified solutions Minimum High School graduate; Bachelor's or Associate's degree desired2+ years of overall experience in Manufacturing, Quality or EngineeringMinimum 5 years experience in a Manufacturing and/or Finishing and/or Packaging environment is desiredMinimum 2 years experience in Batch Record Release strongly preferredKnowledge of GMP regulations and standards affecting pharmaceutical productsGood verbal and written communication skillsDemonstrated analytical skills and attention to detailGood interpersonal relations/communications skillsMust be available to work daily overtime, including weekends, as neededThis is a 3rd Shift position: Hours: 7pm-7:30am, Sunday - Tuesday every other Saturday
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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion, 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