Pharma Quality Auditor - GMP, 3 Shifts

Monroechamber; Winnebago Court (IL); On-site; USD 22,000 - 28,000; Full time

Job summary

Monroechamber is seeking a Quality Auditor to provide hands-on production floor support in Rockford, IL. You will verify cGMP compliance, audit manufacturing processes, and drive continuous improvement in a highly regulated pharmaceutical environment.

You will review batch records, logs, and calibration data, participate in improvement teams, and support root cause analysis while ensuring 5S compliance and safe operations on the floor.

Qualifications

• Experience conducting production floor audits to verify processes and compliance.
• Strong ability to review batch records, logs, and equipment calibration data.
• Familiarity with 5S principles and Kaizen mindset to drive improvements.

Responsibilities

• Perform production room approvals after product and lot changes.
• Verify first piece inspection for correct finished goods code, format, and expiration date.
• Ensure equipment packaging and calibration dates meet specifications; initiate recalibration if needed.
• Review batch records to confirm hourly inspections and address non-conformances.
• Conduct periodic checks to ensure hourly inspections are on track to requirements.
• Audit sampling pages for proper labeling and documentation of samples.
• Ensure logbooks (Cleaning, Use, Mechanical Setup, Preventive Maintenance) are complete.

Skills

Quality auditing

cGMP compliance

GCP compliance

Documentation

Root Cause Analysis

Job description

Monroechamber is seeking a Quality Auditor to provide hands-on production floor support in Rockford, IL. You will verify cGMP compliance, audit manufacturing processes, and drive continuous improvement in a highly regulated pharmaceutical environment.

You will review batch records, logs, and calibration data, participate in improvement teams, and support root cause analysis while ensuring 5S compliance and safe operations on the floor.