Quality Systems Auditor

Kdc One; Madison Township (OH); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health/Vision/Dental/401k/bonus

10 Paid Holidays

Paid Vacation Days

Job summary

Kdc/one, located in Groveport, Ohio, is hiring a Quality Systems Auditor to review batch records, ensure cGMP conformance, and manage documentation and QA processes. The role involves auditing records, coordinating with departments, and supporting corrective actions to maintain product quality.

The ideal candidate has a high school diploma (college courses preferred), experience in technical documentation and auditing, and SAP familiarity. Strong attention to detail and compliance are essential.

Qualifications

• High School Diploma; college courses preferred.
• Experience with preparing, auditing and editing technical information, records, documents and/or reports.
• SAP experience preferred.

Responsibilities

• Audit batch records to ensure documentation meets cGMP and customer specs.
• Identify discrepancies during audits and request resolutions from relevant departments.
• Generate and distribute Certificates of Analysis for batches manufactured and packaged as required by customers.
• Review and verify inventory movements in SAP, including issuance/return of materials.
• Monitor finished goods quality status during release to ensure on-time, complete shipments.
• Initiate non-conformances in the Trackwise system and support investigations and corrective actions.

Skills

Auditing

Documentation

Quality systems

Education

High School Diploma

Tools

SAP

Job description

About us:

Kdc/one is currently hiring at our Groveport, Ohio location. As part of the kdc/one network, we are the leading best-in-class producer of beautyand personal care products! Our Groveport location is accessible with an easy commute located on RT. 33/Hamilton Rd.

We offer excellent opportunities for advancement at all of our sites and are excited to have you jointhe kdc/one Team!

General Information:

The Quality Systems Auditor is responsible for auditing information, records, and documents generated throughout the manufacturing process to ensure products are produced in accordance to all applicable Standard Operating Procedures (SOPs), Work Instructions (WI), cGMP practices, and other specifications or requirements defined by the Company and/or our customers.

What are we looking for?

• High School Diploma with some college courses, preferred. In lieu of college courses, years of experience, knowledge, skills, and fit will be considered.
• Experience with preparing, auditing and editing technical information, records, documents, and/or reports, preferred.
• SAP experience, preferred.

Benefits Include:

• Competitive Wages/Salary
• Health/Vision/Dental/401k/bonus potential!
• 10 Paid Holidays
• Paid Vacation Days
• Immediate openings

This position is responsible for:

• Audits batch records to ensure all related documentation have been submitted accurately and within the guidelines of the Company's cGMP policies and procedures, as well as the manufacturing specifications set forth by our customers.
• Communicates discrepancies and/or errors found during the batch record audits, and requests resolution from the appropriate departments.
• Generates and distributes the Certificates of Analysis for any batches manufactured and packaged as required by our customers.

• Reviews and verifies inventory movements and quantities in SAP, including the issuance and return of materials into stock, product batch transactions, and inventory transfer status changes.
• Monitor the quality status of finished good products throughout the release process to ensure scheduled shipment orders are filled on-time and in-full.
• Report any raw material inventory approaching their expiration and retesting dates to ensure quality requirements are maintained.
• Initiate any applicable non-conformances in the Company's quality tracking system, Trackwise; provide support in the investigation, corrective action and/or completion of non-conformance activities.
• Exchange information related to the planning and prioritization of products/materials, process validations, batch processing and release, documentation gaps, and other related activities with respective departments.
• Processes transactions in SAP necessary to maintain the appropriate inventory status for manufacturing, packaging and shipping products.
• Maintains and files all records related to product batches, and other business transactions in accordance with applicable retention policies.

• Performs all work in a manner that is consistent with the company's quality system and FDA good manufacturing practices, includes maintaining a clean and orderly production area at all times.
• Follows, promotes, and enforces KDC's safety and environmental policies, practices, and procedures.

• Assists with safety investigations and corrective actions related to safety hazards and/or incidents.
• Performs other duties as assigned.