Quality Systems Auditor

kdc/one•Groveport, OH

4d•Onsite

About The Position

The Quality Systems Auditor audits information, records, and documents generated throughout manufacturing to ensure products are produced 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 accurate batch documentation, product quality and release, inventory control, records retention, and compliance with the company quality system and FDA good manufacturing practices. The position is based at KDC/one’s Groveport, Ohio location.

Requirements

High school diploma; some college courses are preferred. Relevant years of experience, knowledge, skills, and fit may be considered in lieu of college courses.
Experience preparing, auditing, and editing technical information, records, documents, and/or reports is preferred.
SAP experience is preferred.

Nice To Haves

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

Responsibilities

Audit batch records for accurate and complete documentation in accordance with 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 manufactured and packaged batches 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 finished-goods quality status through the release process 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 investigations, corrective actions, and completion of non-conformance 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 product-batch and other business-transaction records in accordance with applicable 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 safety hazards or incidents.
Perform other duties as assigned.