- 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.
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 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.
Skills, experience or education:
- 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
Job Type: Contract
Pay: $39.00 - $40.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Work Location: In person