Pharma QA Specialist — GMP & Compliance Expert

MedPharm Ltd; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

MedPharm Ltd seeks a QA Specialist to provide Quality Assurance support for IMP manufacturing and associated QMS. The role ensures compliance with GMP, GCP, GLP and regulatory requirements through review of quality documentation, QMS management, and QA oversight of manufacturing and laboratory activities.

You will collaborate with Production, QC and Development teams to maintain compliant quality systems and timely release of products.

Qualifications

• Bachelor's or Master’s degree in a scientific discipline or equivalent industry experience.
• Minimum 2 years in a GMP-regulated pharmaceutical or biotech environment, preferably GMP/IMP support.
• QMS experience including deviations, CAPAs, change controls and investigations.

Responsibilities

• Review and manage Quality Management System records (deviations, CAPAs, investigations, change controls).
• Review and approve controlled documents (SOPs, specs, reports) for GDP/data integrity.
• Provide QA oversight during manufacturing and laboratory activities to ensure compliance with GMP/GLP.
• Support audits, inspections and CAPA follow-up; assist with inspection readiness.

Skills

GMP knowledge

GCP knowledge

GLP knowledge

QMS experience

Education

Bachelor/Master in a scientific discipline

Tools

MasterControl

Job description

MedPharm Ltd seeks a QA Specialist to provide Quality Assurance support for IMP manufacturing and associated QMS. The role ensures compliance with GMP, GCP, GLP and regulatory requirements through review of quality documentation, QMS management, and QA oversight of manufacturing and laboratory activities.

You will collaborate with Production, QC and Development teams to maintain compliant quality systems and timely release of products.