Viral Vector QA Specialist II — Onsite, Houston

Lonza Biologics, Inc.; Houston (TX); On-site; Confidential; Full time

Benefits offered by this job

Bonus

Medical/Dental/Vision

401(k) match

Life & Disability Insurance

Employee Assistance Programs

PTO

Job summary

Lonza Biologics, Inc. is seeking a Quality Assurance Specialist II - Viral Vector in Houston, onsite. You will oversee quality for viral vector manufacturing, ensuring cGMP compliance and quality systems integration across manufacturing, QC, and engineering teams.

The role involves supporting floor activities, reviewing batch records, and driving CAPAs and deviations. Strong attention to detail, gowning expertise, and cross-functional teamwork are essential for success in this fast-paced

Qualifications

• Associates degree in Life Sciences, Engineering, or related discipline preferred.
• Experience in GMP-regulated biopharmaceutical, biologics, cell therapy, or viral vector manufacturing.
• Hands-on cleanroom and Level 3 gowning experience.
• Experience reviewing GMP documentation and batch records with attention to detail.
• Knowledge of deviations, CAPAs, change controls, and quality systems processes.
• Strong communication and cross-functional collaboration skills.
• Cell therapy and/or viral vector manufacturing experience preferred.
• Demonstrated commitment to quality, compliance, and patient safety.

Responsibilities

• Provide quality oversight for viral vector and cell therapy manufacturing operations, ensuring cGMP compliance.
• Support manufacturing floor activities with QA presence, including line clearances and critical operations support.
• Review and approve Master Batch Records, executed batch records, and GMP documentation for product disposition.
• Perform QA walkthroughs and collaborate to identify, investigate, and resolve quality issues.
• Support investigations, deviations, CAPAs, change controls, and other quality system processes.
• Ensure ISO, GMP, and regulatory compliance and maintain inspection readiness.
• Perform cleanroom activities requiring Level 3 gowning to support manufacturing operations.
• Maintain accurate tracking of quality records and drive continuous improvement initiatives.

Skills

GMP compliance

Quality oversight

Cleanroom gowning

Documentation review

Cross-functional collaboration

Problem solving

Attention to detail

Auditing & CAPA basics

Education

Associates degree in Life Sciences, Engineering, or related discipline

Job description

Lonza Biologics, Inc. is seeking a Quality Assurance Specialist II - Viral Vector in Houston, onsite. You will oversee quality for viral vector manufacturing, ensuring cGMP compliance and quality systems integration across manufacturing, QC, and engineering teams.

The role involves supporting floor activities, reviewing batch records, and driving CAPAs and deviations. Strong attention to detail, gowning expertise, and cross-functional teamwork are essential for success in this fast-paced