Senior Quality Specialist, CAPA II
1 month ago
At AbbVie, we are committed to delivering innovative medicines and solutions that address serious health issues. We are seeking a highly skilled Senior Quality Specialist, CAPA II to join our team.
Job Summary:The Senior Quality Specialist, CAPA II will be responsible for overseeing 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.
Key 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
- 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 a 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
We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.
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.
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