Quality Systems Auditor - kdc/one Columbus
About The Position
Join KDC/One as a Quality Systems Auditor and help ensure our products meet the highest standards of quality, compliance, and customer expectations. Key Responsibilities: Audit batch records for compliance with cGMPs, manufacturing specifications, and documentation requirements. Identify, communicate, and coordinate resolution of batch record discrepancies with cross-functional teams. Generate and distribute Certificates of Analysis in accordance with customer requirements. Review and process inventory transactions in SAP, including material movements and inventory status changes. Monitor finished goods quality status to support on-time and in-full product release and shipment. Track raw material expiration and retest dates and report potential quality risks. Initiate and support non-conformances, investigations, and corrective actions in Trackwise. Maintain quality records per retention policies and ensure compliance with FDA, quality, safety, and environmental standards.
Requirements
- High School Diploma or GED required (college coursework preferred).
Nice To Haves
- Experience preparing, auditing, or editing technical records, documents, or reports preferred.
- SAP experience preferred.
Responsibilities
- Audit batch records for compliance with cGMPs, manufacturing specifications, and documentation requirements.
- Identify, communicate, and coordinate resolution of batch record discrepancies with cross-functional teams.
- Generate and distribute Certificates of Analysis in accordance with customer requirements.
- Review and process inventory transactions in SAP, including material movements and inventory status changes.
- Monitor finished goods quality status to support on-time and in-full product release and shipment.
- Track raw material expiration and retest dates and report potential quality risks.
- Initiate and support non-conformances, investigations, and corrective actions in Trackwise.
- Maintain quality records per retention policies and ensure compliance with FDA, quality, safety, and environmental standards.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
