Quality Assurance Specialist – Gene Therapy GMP Operations

PACKGENE BIOTECH INC; Houston (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

PACKGENE BIOTECH INC is seeking a Quality Assurance Specialist at our Houston, TX cGMP facility to support manufacturing operations. This role provides independent QA oversight, reviews GMP documentation, and ensures compliance with regulatory expectations and internal standards.

You will collaborate with Manufacturing, QC, and other functions, drive deviation investigations, CAPA actions, and batch disposition to ensure timely, quality product releases for clinical-stage gene therapies.

Qualifications

• Support GMP manufacturing operations and quality systems.
• Review and approve GMP documents and records.
• Perform QA-on-the-floor oversight of operations.
• Lead deviation investigations, CAPA development, and batch release.
• Ensure compliance with cGMP regulatory expectations.

Responsibilities

• Review and approve Quality System records (deviations, CAPAs, investigations, risk assessments).
• Develop, review, and approve GMP documentation.
• Review batch records and GMP documentation for compliance.
• Provide real-time QA oversight on the manufacturing floor.
• Oversee aseptic processing and critical GMP operations.
• Coordinate batch record review and disposition before final release.

Skills

Quality Assurance

GMP documentation

QA on the floor

Deviations & CAPAs

Batch disposition

Regulatory compliance

Customer interaction

cGMP knowledge

Education

Bachelor's degree in Biology/Biotech

Job description

PACKGENE BIOTECH INC is seeking a Quality Assurance Specialist at our Houston, TX cGMP facility to support manufacturing operations. This role provides independent QA oversight, reviews GMP documentation, and ensures compliance with regulatory expectations and internal standards.

You will collaborate with Manufacturing, QC, and other functions, drive deviation investigations, CAPA actions, and batch disposition to ensure timely, quality product releases for clinical-stage gene therapies.