- The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.
Reviewer, Batch Record II - North Chicago, United States - AbbVie
Description
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
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
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Qualifications
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
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Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: