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. 

Purpose

Provides quality assurance support for projects, which may include, internal projects, and projects from contract manufacturing customers. This support may include, but is not limited to, the following areas: documentation support, batch record review, SOP review and revision, investigation of OOS materials and products, and participation in project team activities.

Responsibilities

• Review all production batch records for the manufacture of Humira, clinical manufacturing projects and contract manufacturing projects against specifications, and authorize release of materials or product.
• Work as a liaison between the operating groups and the Document Control group to facilitate the identification, writing, reviewing, and approval of all documents to support a given project.
• Ensure GMP and operational compliance with documentation related to the production of a batch or lot of material. This is accomplished through the systematic review of all the batch-related documents. Once all the documentation has been reviewed and signed off, assemble a batch disposition package which authorizes the approval or rejection of the given batch or lot.
• Participate in project team meetings as representative for QA/Document Control group. Ensure overall GMP compliance with project through coordination of documentation, batch record review, and other means
• Review and investigate exception reports for out of specification materials or products. Work with Production and Quality Control to investigate issues, determine causes, and identify and implement corrective actions.
• Provide Quality Assurance support for a variety of projects at the site, including, but not limited to, process improvements, compliance for newly built manufacturing suites, better yields in production area, etc.
• Interact with auditors from the FDA and/or contract manufacturing companies. Respond to auditor requests for files, documentation, records, reports, etc.
• Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation, Division, and Location.
• Provide support on QA initiatives / special projects when necessary.
• Work independently and release raw materials and components based on approved specifications
  • Use of discretion and independent judgment on final disposition of raw materials and component materials for use in manufacturing of biologics.

• BS in a scientific discipline, or equivalent experience
• 3+ years experience in a GMP-related field
• Working knowledge of GMPs and their documentation
• Experience with batch record review and working knowledge of batch release
• Ability to work well in a project team environment
• Good oral, written, and presentation skills
• Strong computer skills utilizing a Microsoft environment (e.g. word, excel, access, PowerPoint)

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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. ​

  
  

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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. ​

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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