QA Specialist II, Viral Vector – Cell Therapy

Lonza; Houston (TX); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Performance bonus

401(k) matching

Employee assistance programs

Paid time off (PTO)

Job summary

Lonza in Houston, TX is seeking a Quality Assurance Specialist II - Viral Vector to ensure quality and compliance across viral vector and cell therapy manufacturing operations. The role partners with Manufacturing, Quality Control, and Engineering to support production activities, maintain cGMP compliance, and deliver life-changing therapies.

This onsite position requires cleanroom gowning and active QA involvement on the floor to support line clearances, deviations, and CAPAs, while ensuring

Qualifications

• Associates degree in Life Sciences, Engineering, or related discipline preferred.
• GMP-regulated biopharmaceutical or viral vector manufacturing experience.
• Hands-on cleanroom/gowning experience in classified environments.
• Experience reviewing GMP documentation and batch records.
• Strong communication and cross-functional collaboration.

Responsibilities

• Provide quality oversight for viral vector and cell therapy manufacturing operations, ensuring compliance with cGMP, GDP, and quality system requirements.
• Support manufacturing floor activities through QA presence on the floor, including line clearances and critical operations support.
• Perform QA walkthroughs and collaborate with Manufacturing to identify, investigate, and resolve quality issues.
• Support investigations, deviations, CAPAs, change controls, and other quality system processes.
• Ensure compliance with ISO, GMP, and regulatory requirements while maintaining inspection readiness.
• Perform cleanroom activities requiring Level 3 gowning (Grade B) to support manufacturing operations and quality oversight.
• Maintain accurate tracking of quality records and support continuous improvement initiatives.

Skills

QA oversight

Cleanroom experience

GMP documentation

Cross-functional collaboration

Problem solving

Education

Associates degree in Life Sciences or related

Job description

Lonza in Houston, TX is seeking a Quality Assurance Specialist II - Viral Vector to ensure quality and compliance across viral vector and cell therapy manufacturing operations. The role partners with Manufacturing, Quality Control, and Engineering to support production activities, maintain cGMP compliance, and deliver life-changing therapies.

This onsite position requires cleanroom gowning and active QA involvement on the floor to support line clearances, deviations, and CAPAs, while ensuring