Quality Assurance Specialist II — Viral Vector Manufacturing

Lonza; Houston (TX); On-site; Confidential; Full time

Benefits offered by this job

Performance bonus

Medical coverage

Dental insurance

Vision insurance

401(k) matching

Life insurance

Disability insurance

Employee assistance program

Paid time off

Job summary

Lonza Houston seeks a Quality Assurance Specialist II for Viral Vector operations. The role focuses on maintaining cGMP compliance and partnering with Manufacturing, Quality Control, and Engineering to support production activities.

You will review batch records, participate in investigations, and ensure readiness for inspections in a fast-paced biopharma environment. The ideal candidate has GMP experience, cleanroom work, and strong attention to detail, with communication skills to collaborate

Qualifications

• Associates degree in Life Sciences, Engineering, or related field preferred.
• Experience in GMP-regulated biopharmaceutical environments.
• Hands-on cleanroom and gowning experience in classified manufacturing areas.
• Experience reviewing GMP documentation and batch records with attention to detail.
• Knowledge of deviations, CAPAs, change controls, and quality systems.

Responsibilities

• Provide QA oversight for viral vector and cell therapy manufacturing within cGMP/GDP frameworks.
• Support floor activities with QA presence: line clearances, critical operations, quality decisions.
• Review and approve Master 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 with Level 3 gowning (Grade B).
• Maintain quality records and drive continuous improvement initiatives.

Skills

QA oversight

GMP compliance

Cross-functional

Problem solving

Attention to detail

Communication skills

Cell therapy knowledge

Viral vector experience

Education

Associates degree in Life Sciences

Job description

Lonza Houston seeks a Quality Assurance Specialist II for Viral Vector operations. The role focuses on maintaining cGMP compliance and partnering with Manufacturing, Quality Control, and Engineering to support production activities.

You will review batch records, participate in investigations, and ensure readiness for inspections in a fast-paced biopharma environment. The ideal candidate has GMP experience, cleanroom work, and strong attention to detail, with communication skills to collaborate