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).
Numbers & Facts
Location
Illinois City, IL
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Calibrationunmatched
Change Controlunmatched
Change Requests/Ordersunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Detail Orientedunmatched
Documentationunmatched
Documentation Reviewunmatched
FDA Requirementsunmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
Internal Auditunmatched
Laboratory Equipmentunmatched
Laboratory Operationsunmatched
Laboratory Systemsunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Operationsunmatched
Pharmacyunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Process Validationunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Quality Engineeringunmatched
Quality Metricsunmatched
Quality Monitoringunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Technical Writingunmatched
Validation Documentationunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.