Quality Assurance Specialist III GMP Houston

Scorpion Therapeutics; Houston (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Neurogene is seeking a Quality Assurance Specialist to support GMP compliance and quality oversight in gene therapy manufacturing operations. You will review GMP documentation, lead deviation investigations, and support manufacturing and validation activities on the floor while ensuring inspection readiness and driving continuous improvement of quality systems.

The role requires collaboration with Manufacturing, QC, Validation, and Engineering teams to provide QA support across operations, with

Qualifications

• Bachelor's in life sciences or related field.
• 4–6 years biotech/pharma experience.
• Strong knowledge of cGMP biologics manufacturing, aseptic processes and cell biology.
• GMP/Quality certifications preferred.

Responsibilities

• Review and approve GMP documentation.
• Lead investigations of deviations.
• Support manufacturing and validation activities.
• Ensure regulatory inspection readiness.
• Contribute to continuous improvement of quality systems.

Skills

GMP compliance

QA floor support

Deviation investigations

cGMP biologics

Aseptic processes

Cell biology

Education

Bachelor's in life sciences

Job description

Role

Quality Assurance Specialist supporting GMP compliance and quality oversight in Neurogene's gene therapy manufacturing operations. Responsibilities: review and approve GMP documentation, lead investigations of deviations, support manufacturing and validation activities, ensure regulatory inspection readiness, and contribute to continuous improvement of quality systems. Collaborates closely with Manufacturing, QC, Validation, and Engineering teams, providing on-the-floor QA support and guidance.

Requirements

Bachelor's in life sciences or related field; 4-6 years of biotech/pharma experience; strong knowledge of cGMP biologics manufacturing, aseptic processes, and cell biology; GMP/Quality certifications preferred.

High-Value

Focus on biologics, gene therapy, GMP compliance, validation, and manufacturing quality within a clinical-stage biopharma environment transitioning from preclinical to IND-enabling studies.

Work setup

Onsite Houston, TX; travel as needed.