Senior QA Specialist - Viral Vector & Cell Therapy

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

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance, short-term and long‑/–

Employee assistance programs

Paid time off (PTO)

Job summary

Lonza Biologics, Inc. in Houston, TX is seeking a senior Quality Assurance Specialist III - Viral Vector to ensure quality and compliance across viral vector, cell therapy, and advanced therapy manufacturing.

The role partners with Manufacturing, QC, Engineering, and Facilities to provide QA oversight on the floor, lead complex investigations, and drive continuous improvement while mentoring teammates. The position emphasizes responsibility for complex quality issues, regulatory readiness, and

Qualifications

• Associate’s or Bachelor's degree in Life Sciences, Engineering, or related field preferred.
• Experience in GMP-regulated biopharmaceutical environments with viral vectors or cell therapy.
• Experience reviewing GMP documents and batch records with attention to detail.
• Hands-on QA floor support and cleanroom activities experience.
• Experience managing deviations, investigations, CAPAs, and change controls.
• Knowledge of cGMP, GDP, ISO standards and regulatory requirements.
• Strong communication and collaboration skills across functions.
• Ability to resolve complex quality issues in a fast-paced setting.
• Leadership or mentoring experience preferred.
• 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 and real-time decision making.
• Review and approve Master Batch Records and GMP documents to support batch disposition.
• Lead investigations, deviations, CAPAs, and change controls using structured problem solving.
• Review quality system records generated by Manufacturing, QC, and other departments.
• Provide informal leadership and guidance within the QA team and cross-functional groups.
• Maintain inspection readiness and ensure regulatory compliance.
• Perform cleanroom activities with gowning and direct QA oversight in classified environments.
• Manage multiple priorities while maintaining quality record accuracy and operational excellence.

Skills

GMP compliance

Viral vector manufacturing

QA oversight

Deviations & CAPAs

Master Batch Records

GxP

Cleanroom operations

Cross-functional collaboration

Education

Bachelor's in Life Sciences/Engineering

Associate’s degree

Job description

Lonza Biologics, Inc. in Houston, TX is seeking a senior Quality Assurance Specialist III - Viral Vector to ensure quality and compliance across viral vector, cell therapy, and advanced therapy manufacturing.

The role partners with Manufacturing, QC, Engineering, and Facilities to provide QA oversight on the floor, lead complex investigations, and drive continuous improvement while mentoring teammates. The position emphasizes responsibility for complex quality issues, regulatory readiness, and