Senior GMP QA Specialist III — Biotech Manufacturing

Neurogene Inc.; Houston (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Neurogene Inc. is seeking a QA Specialist III to join our Houston team and ensure GMP compliance across manufacturing and QA documentation.

This role collaborates with Manufacturing, QC, MSAT, Validation, Engineering, and Supply Chain to support IND filings and transition to accelerated clinical development. The ideal candidate will have 4–6 years in biotech/pharma with GMP and aseptic manufacturing knowledge, strong communication, and problem-solving abilities.

Qualifications

• Bachelor’s degree in life sciences, chemistry, biology or related field.
• 4–6 years of biotech/pharmaceutical industry experience.
• GMP/gxP knowledge and aseptic manufacturing experience.
• Excellent communication and problem-solving skills.

Responsibilities

• Performs independent QA review and approval of GMP documentation and records.
• Leads minor to moderate deviations, investigations, CAPAs, OOS, and change controls; conducts root cause analysis.
• Provides QA oversight on manufacturing operations including room release and product disposition.
• Supports regulatory inspections and internal audits as a quality resource.
• Maintains controlled documents and ensures alignment with GMP requirements.

Skills

cGMP knowledge

GxP compliance

Documentation review

Cross-functional collaboration

Quality decision making

Education

Bachelor's degree in life sciences

Job description

Neurogene Inc. is seeking a QA Specialist III to join our Houston team and ensure GMP compliance across manufacturing and QA documentation.

This role collaborates with Manufacturing, QC, MSAT, Validation, Engineering, and Supply Chain to support IND filings and transition to accelerated clinical development. The ideal candidate will have 4–6 years in biotech/pharma with GMP and aseptic manufacturing knowledge, strong communication, and problem-solving abilities.