Quality Assurance Auditor I

Position Summary

The Quality Assurance (QA) Auditor I is responsible for batch review and release and assists in investigation of reported product quality issues and internal non-conformance issues. The QA Auditor I is also responsible for meeting all other tasks assigned via their yearly goals set by the Quality Manager. The position reports to the Quality Manager.

Responsibilities & Duties

• Aware of GMPs and GLPs and maintains compliance with those regulations
• Performs batch review and product release activities for the Indianapolis site
• Prepares paperwork for samples being sent to the QC laboratory
• Supports sending samples for external testing
• Supports internal quality audits
• Partners with quality control, operations, engineering, maintenance, safety and supply chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions of product quality issues, INC issues and other manufacturing deviations
• Fosters collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of INC issues
• Documents all investigation activities in detailed, timely reports utilizing Colorcon’s Customer Support Solution (CSS)
• Initiates INC service Requests (SRs)
• Issue necessary quality paperwork for SR related operations
• Assists with new hire training for employees
• Assists with document retention

Minimum Qualifications

• Bachelor’s degree in a physical science preferred or a minimum of 2 years quality auditing experience required
• Ability to work comfortably in the manufacturing area
• Ability to communicate effectively at all levels verbally and in written reports
• Experience in technical writing strongly preferred
• Consistent attention to detail
• Excellent organizational and decision-making skills
• Prior experience in problem solving techniques highly desirable