Specialist, CAPA 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 . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

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.

Responsibilities

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

Qualifications

• 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

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.

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