Quality Engineer - Katalyst Healthcares & Life Sciences
North Chicago, IL 60044
About the Job
Responsibilities:
- Supports the plant Exception Report/CAPA System by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for Client North Chicago product manufacturing and packaging.
- 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.
- 4-6 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.
Source : Katalyst Healthcares & Life Sciences