Quality Assurance Specialist II - Viral Vector

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

Quality Assurance Specialist II - Viral Vector

Location: Houston, Texas – Onsite

Shift: Monday through Friday, 7:30 AM – 4:00 PM

As a Quality Assurance Specialist II - Viral Vector, you will serve as a key representative of the Quality Assurance organization, ensuring quality and compliance standards are maintained across viral vector and advanced therapy manufacturing operations. This role provides the opportunity to partner closely with Manufacturing, Quality Control, Engineering, and other support functions to support production activities, maintain cGMP compliance, and help deliver life-changing therapies to patients.

What you will get:

A competitive compensation package. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus
• Medical, dental and vision insurance
• 401(k) matching plan
• Life insurance, as well as short-term and long-term disability insurance
• Employee assistance programs
• Paid time off (PTO)

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• 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, critical operations support, and quality-related decision making.
• Review and approve Master Batch Records, executed batch records, and supporting GMP documentation to support product disposition and manufacturing execution.
• Perform QA walkthroughs and collaborate with Manufacturing and support groups to identify, investigate, and resolve quality and compliance issues.
• Support investigations, deviations, CAPAs, change controls, and other quality system processes using structured problem-solving approaches.
• 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 that strengthen quality and operational excellence.

What we are looking for:

• Associates degree in Life Sciences, Engineering, or a related scientific discipline preferred. Relevant industry experience may be considered in lieu of degree requirements.
• Experience working in a GMP-regulated biopharmaceutical, biologics, cell therapy, or viral vector manufacturing environment.
• Hands-on cleanroom and gowning experience, including the ability to work within classified manufacturing environments.
• Experience reviewing GMP documentation and batch records with strong attention to detail.
• Knowledge of deviations, CAPAs, change controls, and quality systems processes preferred.
• Strong communication skills and the ability to effectively collaborate with cross-functional teams.
• Demonstrated problem-solving skills and the ability to make sound decisions in a fast-paced manufacturing environment.
• Cell therapy and/or viral vector manufacturing experience preferred.
• Strong work ethic, proactive mindset, and commitment to quality, compliance, and patient safety.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.

If you're ready to help turn breakthrough science into life-changing therapies, we look forward to welcoming you on board.