Gene Therapy QC Analyst — GMP & Data Integrity

MeiraGTx; London Borough of Hackney; On-site; GBP 42,000 - 60,000; Full time

Job summary

MeiraGTx seeks a QC Analytical Scientist to test gene therapy products and materials to EU and FDA GMP standards. You will ensure testing aligns with production schedules, maintain equipment and documentation, and support audits and training. A background in GMP, quality control, and analytical methods is essential.

The role involves maintaining QC facilities, contributing to SOP updates, and collaborating with Production to meet timelines while upholding data integrity and regulatory compliance.

Qualifications

• Degree in Health or Sciences or equivalent experience in regulated industry.
• Knowledge of GMP/GLP/GCP and data integrity practices.
• Proficiency with Microsoft Office (Word/Excel/PowerPoint).

Responsibilities

• GMP compliance is maintained in all activities.
• Ensure quality control data integrity and proper documentation.
• Support internal and external audits and training activities.

Skills

QC testing

GMP compliance

Analytical aptitude

Problem solving

Leadership

Communication

Planning & organizing

Education

Bachelor's degree in Health/Science

Tools

MS Office

Job description

MeiraGTx seeks a QC Analytical Scientist to test gene therapy products and materials to EU and FDA GMP standards. You will ensure testing aligns with production schedules, maintain equipment and documentation, and support audits and training. A background in GMP, quality control, and analytical methods is essential.

The role involves maintaining QC facilities, contributing to SOP updates, and collaborating with Production to meet timelines while upholding data integrity and regulatory compliance.