Quality Systems Auditor

kdc/one•Groveport, OH

3d•Onsite

About The Position

The Quality Systems Auditor audits information, records, and documents generated throughout the manufacturing process to ensure products are made in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), current Good Manufacturing Practices (cGMP), and other company or customer requirements. The role supports batch documentation review, product release, inventory accuracy, quality-system activities, and coordination with relevant departments. The position is at KDC/one’s Groveport, Ohio location.

Requirements

High school diploma; some college coursework is preferred. In lieu of college coursework, relevant years of experience, knowledge, skills, and fit will be considered.

Nice To Haves

Experience preparing, auditing, and editing technical information, records, documents, and/or reports.
SAP experience.

Responsibilities

Audit batch records to ensure documentation is submitted accurately and meets company cGMP policies and procedures and customer manufacturing specifications.
Communicate discrepancies or errors found during batch record audits and request resolution from the appropriate departments.
Generate and distribute Certificates of Analysis for batches manufactured and packaged, as required by customers.
Review and verify inventory movements and quantities in SAP, including material issuance and returns, product batch transactions, and inventory transfer status changes.
Monitor the quality status of finished goods during release to help ensure scheduled shipment orders are filled on time and in full.
Report raw material inventory approaching expiration or retesting dates.
Initiate applicable non-conformances in Trackwise and support investigation, corrective action, and completion activities.
Exchange information with relevant departments about product and material planning and prioritization, process validations, batch processing and release, documentation gaps, and related activities.
Process SAP transactions needed to maintain appropriate inventory status for manufacturing, packaging, and shipping.
Maintain and file records related to product batches and other business transactions in accordance with retention policies.
Perform work consistently with the company quality system and FDA good manufacturing practices, including maintaining a clean and orderly production area.
Follow, promote, and enforce KDC safety and environmental policies, practices, and procedures.
Assist with safety investigations and corrective actions related to hazards or incidents.
Perform other duties as assigned.