Senior Quality Engineer – GMP, Validation & CAPA

MedPharm; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

MedPharm is seeking a Quality Engineer II-III to design, implement, and maintain the Quality Management System across the manufacturing lifecycle, supporting process validation and deviations with root-cause investigations.

You will oversee CAPAs, batch release review, and audits for GMP, GLP, and clinical programs, collaborating with manufacturing, engineering, supply chain, and QA teams to drive continuous improvement.

Qualifications

• B.A./B.S. in an engineering discipline or equivalent experience preferred.
• Quality Assurance experience in the pharmaceutical industry for 5+ years.
• Knowledge of GMP/GLP and FDA regulations relevant to manufacturing.

Responsibilities

• Design, implement and maintain the Quality Management System across manufacturing lifecycle.
• Support process validation and root-cause investigations for deviations.
• Oversee CAPA, batch record review and batch release for GMP, clinical and commercial programs.
• Conduct internal audits and prepare readiness documents for external inspections.

Skills

Quality Assurance

FDA 21 CFR 210/211

ICH Q10

CAPA management

FMEA

Root cause analysis

GMP/GLP knowledge

Statistical/QA analytics

Documentation control

Audits (internal/external)

Education

B.A./B.S. in engineering or equivalent

5+ years QA in pharma industry

Tools

MS Office (Excel, Word, Outlook, Project)

Adobe Pro

Job description

MedPharm is seeking a Quality Engineer II-III to design, implement, and maintain the Quality Management System across the manufacturing lifecycle, supporting process validation and deviations with root-cause investigations.

You will oversee CAPAs, batch release review, and audits for GMP, GLP, and clinical programs, collaborating with manufacturing, engineering, supply chain, and QA teams to drive continuous improvement.