Senior QA Consultant — Gene Therapy GMP Onsite

Kelly Services; Houston (TX); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Transit spending account

Paid holidays

Retirement savings plan

Medical insurance

Dental insurance

Vision insurance

Paid sick leave

Job summary

Kelly Services is seeking a Sr. Quality Assurance Consultant in Houston, TX, to oversee GMP QA for gene therapy manufacturing. The role emphasizes on-the-floor oversight, batch record review, deviations and CAPAs, and collaboration with cross-functional teams.

The ideal candidate has a biology/chemistry/biotech/engineering background with 8+ years of GMP QA experience in gene therapy and regulatory knowledge to ensure inspection readiness.

Qualifications

• Bachelor's degree in a scientific/technical discipline.
• 8+ years of GMP QA experience in gene therapy.
• Direct QA support on manufacturing floor.

Responsibilities

• Provide on-the-floor GMP QA oversight for gene therapy manufacturing operations.
• Review and approve batch records, deviations, CAPAs, change controls, and GMP docs.
• Support DS/DP disposition activities and regulatory readiness.

Skills

GMP QA knowledge

QA on the floor

Regulatory compliance

Analytical reviewing

Risk assessment

Education

Bachelor's degree in Biology, Chemistry, Biotechnology, or Engineering

Job description

Kelly Services is seeking a Sr. Quality Assurance Consultant in Houston, TX, to oversee GMP QA for gene therapy manufacturing. The role emphasizes on-the-floor oversight, batch record review, deviations and CAPAs, and collaboration with cross-functional teams.

The ideal candidate has a biology/chemistry/biotech/engineering background with 8+ years of GMP QA experience in gene therapy and regulatory knowledge to ensure inspection readiness.