Batch Record Reviewer II

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  www.abbvie.com . Follow @abbvie on  LinkedIn,   Facebook ,  Instagram ,  X  and  YouTube.

Job Description

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 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 agencies

Ensure 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

Additional Information

​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