Specialist, CAPA II

Company Description

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Oversees the plant CAPA Quality System by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for drug product manufacturing and packaging.

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements
• Coordinates the exception document process and creates exception documents
• Independently leads complex, high impact investigations
• Ensures all investigations are written according to corporate and site requirements
• Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System
• Ensures all Quality CAPA goals and metrics are met
• Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions
• Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant

• Bachelor's degree, preferably in one of the following areas:
  Biology, Chemistry or Engineering
• 6+ years of experience in the pharmaceutical industry in Manufacturing, Quality or Engineering
• Demonstrates ability to problem solve and utilize analytical skills
• Knowledge of Quality/Compliance management, Regulations and Standards

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

• 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 thetimeofthis posting based on the job grade for this position.
  
  Individual compensation paid within this range will depend on many factors including geographic location,andwemay ultimately pay more or less than the posted range. This range may be modified in thefuture.
• 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 payis considered to bewages or compensation until such amount is earned, vested, and determinable.

Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company'ssoleandabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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

US & Puerto Rico applicants seeking a reasonable accommodation,  to learn more: