Specialist, CAPA I
About The Position
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 X , Facebook , Instagram , YouTube, LinkedIn and Tik Tok . Purpose: Performs root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for drug product manufacturing and packaging.
Requirements
- Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering
- 4+ years of experience in the pharmaceutical industry in Manufacturing, Quality or Engineering
- Ability to problem solve and utilize analytical skills
- Knowledge of Quality/Compliance management, Regulations and Standards
- Leveling will be commensurate to experience.
Responsibilities
- Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements
- Coordinates the exception document process and creates exception documents
- Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions
- Ensures all investigations are written according to corporate and site requirements
- Participates in implementation and maintenance of the Quality System to meet all applicable regulatory requirements
- Effectively collaborates/partners with other Quality areas and departments within the plant
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
