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Quality Engineer II

2 months ago

North Chicago, United States KYYBA Full time
Job DescriptionJob Description

Position Title: Quality Engineer II
Length of Contract: 6 months, possibility to extend
North Chicago, IL
Interviewing Process: 1 Video Interview and I panel

 

Description:

·        Supports the plant Exception Report/CAPA System by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for 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.

 

What are the top 3-5 skills, experience or education required for this position?

·        Bachelor 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.

·        During training: 100% onsite, After training period: Will support Hybrid schedule of 3 days onsite, 2 days remote. Some weeks will require 100% onsite.