Quality Engineer

Katalyst CRO; Illinois City (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a detail-oriented Quality Engineer in Illinois to support quality engineering activities in manufacturing and laboratories. The ideal candidate will have a Bachelor's degree in a relevant field and over 4 years of experience in the pharmaceutical industry. Responsibilities include ensuring compliance with GMP and quality systems, managing deviations, and supporting FDA audits. Join us to enhance quality engineering efforts and drive continuous compliance improvements.

Qualifications

• 4+ years of experience in Quality Engineering within the pharmaceutical or life sciences industry.
• Strong knowledge of GMP, cGMP, GLP, and regulatory compliance requirements.
• Experience with deviation management, CAPA, change control, and validation processes.

Responsibilities

• Support quality engineering activities for manufacturing and lab operations.
• Review batch records, technical documents, and quality reports for compliance.
• Assist in method development support and validation documentation review.

Skills

Deviations management

CAPA processes

Change control

Validation

GMP compliance

Risk management

Education

Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field

Job description

Summary

We are seeking a detail‑oriented Quality Engineer with experience in the pharmaceutical industry to support quality engineering activities across manufacturing and laboratory operations. The ideal candidate will have hands‑on experience with deviations, CAPA, change control, validation, and GMP compliance.

Roles & Responsibilities

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure compliance with GMP, cGMP, and GLP standards.
• Assist in method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues and improve compliance.
• Participate in root cause investigations for deviations, out‑of‑trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Monitor quality metrics, trends, and recurring issues to drive continuous improvement.
• Assist in internal audits, compliance reviews, and inspection readiness.
• Maintain accurate and compliant quality documentation and records.

Education & Experience

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field.
• 4+ years of experience in Quality Engineering within the pharmaceutical or life sciences industry.
• Strong knowledge of GMP, cGMP, GLP, and regulatory compliance requirements.
• Experience with deviation management, CAPA, change control, and validation processes.
• Ability to review and interpret technical documents, SOPs, and batch records.
• Experience supporting FDA audits or regulatory inspections.
• Knowledge of risk management and quality systems.
• Familiarity with validation lifecycle (IQ, OQ, PQ).