Quality Systems Auditor

KDC One•Groveport, OH

1d•Onsite

About The Position

The Quality Systems Auditor audits information, records, and documents generated throughout the manufacturing process 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 specifications and requirements. The role also supports product release, inventory control, quality-system activities, record retention, and compliance with safety and environmental policies. 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 accuracy and compliance with company cGMP policies and procedures and customer manufacturing specifications.
Communicate discrepancies and errors identified 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 SAP inventory movements and quantities, including material issuance and returns, product batch transactions, and inventory transfer status changes.
Monitor finished-goods quality status throughout 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 the Trackwise quality tracking system 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 product-batch and 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 company safety and environmental policies, practices, and procedures.
Assist with safety investigations and corrective actions related to hazards or incidents.
Perform other duties as assigned.