Auditing, CSS (Cascading Style Sheet), Corrective Action, Customer Service Tools, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Internal Audit, Investigative Reports, Maintain Compliance, Maintenance Services, Manufacturing, Product Reviews, Quality Assurance, Quality Control, Regulatory Compliance, Sample/Specimen Processing, Staff Training, Supply Chain, Team Player, Time Management
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.
- Assists with internal quality audits
- Perform quality review/audit of incoming raw materials and finished products.
- Supports the investigation of customer reported product quality issues, internal non-conformance (INC) issuesand other manufacturing deviations or problems.
- Partners with quality control, operations, engineering, maintenance, safety and supply chain to ensure appropriateand 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 thereduction of INC issues.
- Documents all investigation activities in detailed, timely reports utilizing Colorcon's Customer Support Solution(CSS).
- Responsible for initiating INC service Requests (SRs)
- Issue necessary quality paperwork for SR related operations.
- Assists with new hire training for employees
- Assists with document retention.