GMP Quality Engineer II | Validation & Compliance

MedPharm; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

MedPharm seeks a Quality Engineer II-III to design, implement, and maintain the Quality Management System across the manufacturing lifecycle. You will support process validation, CAPA, and batch release for GMP, clinical, and commercial programs, ensuring FDA/ICH regulatory alignment and cross-functional collaboration.

The role focuses on QA oversight of process controls, documentation, risk assessment, and audit readiness, with opportunities to lead continuous improvement initiatives and

Qualifications

• B.A./B.S. in Engineering or equivalent experience preferred.
• 5+ years QA experience in pharmaceutical manufacturing.
• Knowledge of FDA 21 CFR Parts 210/211, ICH Q10 and cGMP standards.

Responsibilities

• Review and approve validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities, and analytical software.
• Investigate manufacturing deviations and OOS results using root-cause analysis tools.
• Review and approve batch records, specs, and batch release documentation.

Skills

Quality Assurance

Regulatory compliance

Root cause analysis

Process improvement

Documentation

Education

B.A./B.S. in Engineering

5+ years QA in pharma

Tools

MS Office

Adobe Pro

Job description

MedPharm seeks a Quality Engineer II-III to design, implement, and maintain the Quality Management System across the manufacturing lifecycle. You will support process validation, CAPA, and batch release for GMP, clinical, and commercial programs, ensuring FDA/ICH regulatory alignment and cross-functional collaboration.

The role focuses on QA oversight of process controls, documentation, risk assessment, and audit readiness, with opportunities to lead continuous improvement initiatives and