Quality Systems Auditor

Kdc One; Groveport (OH); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Competitive wages

Health/Vision/Dental/401k/bonus

10 paid holidays

Paid vacation days

Immediate openings

Job summary

KDC/one is hiring a Quality Systems Auditor at our Groveport, Ohio location. You will audit records to ensure compliance with SOPs, WI, and cGMP, and support the release of finished goods and batch documentation.

The role requires a High School Diploma (some college preferred) and experience in preparing and auditing technical records, with SAP experience as a plus. Health and retirement benefits are offered, along with paid holidays and vacation days.

Qualifications

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

Responsibilities

• Audits batch records to ensure documentation complies with cGMP and customer specifications.
• Communicates discrepancies and seeks resolution with appropriate departments.
• Generates and distributes Certificates of Analysis for batches produced and packaged as required by customers.
• Reviews inventory movements and quantities in SAP, including issuance and return of materials.
• Monitors quality status of finished goods through release process to ensure on-time shipment.

Skills

HS diploma

Some college

Auditing experience

Technical writing

SAP experience

Education

High School Diploma

Some College Courses

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.