Senior QA Engineer: GMP & Compliance

MedPharm Ltd; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

MedPharm Ltd is seeking a Quality Engineer II-III to lead the quality management activities across GMP manufacturing, from incoming materials to final release. You will collaborate with production, engineering and QA to ensure FDA compliance, execute validations, investigate deviations, and drive CAPA and process improvements across clinical and commercial programs.

Experience in GMP/GLP, QA documentation, and risk assessment is expected, with strong analytical and communication skills to

Qualifications

• 5+ years QA experience in pharma/manufacturing
• Strong knowledge of GMP/GLP and ICH guidelines
• Experience with deviations, CAPA and change control processes
• Experience with validation (IQ/OQ/PQ) and batch record review

Responsibilities

• Ensure FDA 21 CFR Parts 210/211 compliance and ICH Q10.
• Review and approve validation protocols for equipment, facilities, utilities, and analytics.
• Investigate deviations and perform root-cause analysis to support CAPA actions.
• Review batch records and release for GMP, clinical, and commercial programs.
• Lead or support internal audits and assist with external regulatory inspections.
• Collaborate with cross-functional teams to drive continuous quality improvements.

Skills

Quality Assurance

FDA compliance

Root cause analysis

Auditing

Data analysis

MS Office

Education

B.S. in Engineering

Tools

MS Project

Adobe Acrobat

Job description

MedPharm Ltd is seeking a Quality Engineer II-III to lead the quality management activities across GMP manufacturing, from incoming materials to final release. You will collaborate with production, engineering and QA to ensure FDA compliance, execute validations, investigate deviations, and drive CAPA and process improvements across clinical and commercial programs.

Experience in GMP/GLP, QA documentation, and risk assessment is expected, with strong analytical and communication skills to