Quality Specialist

2 weeks ago


North Chicago, United States Sterling Engineering Full time

Purpose


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


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 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



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