What are the responsibilities and job description for the Quality Assurance Specialist II position at Nitto Denko?
About this opportunity :
The position is responsible for documenting and auditing cGMP practices for the site. The position develops and revises QA procedures to strengthen cGMP compliance.
Key Responsibilities :
- Responsible for acting as Project Lead for assigned client manufacturing projects, including reviewing quality records / batch records associated with the project or ensuring that all documents are reviewed and approved as required.
- Responsible for writing / revising Quality Assurance procedures to strengthen compliance with cGMPs.
- Review and approve deviation Provide strong link / communication between the QA function / activities with all other departments at the Cincinnati site.
- Perform quality assurance / compliance related tasks as assigned by the Department Manager. As assigned, provide assistance during cGMP compliance inspections of the Cincinnati facility. This includes the retrieving of quality documents / records / trend data and any other documentation requested during these inspections.
Required Skills / Abilities :
