Quality Assurance Specialist III - Viral Vector (Second Shift)

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, disability insurance

Job summary

Lonza Biologics, Inc. in Houston, TX is seeking a Quality Assurance Specialist III - Viral Vector (Second Shift) to provide senior QA oversight across viral vector, cell therapy, and advanced therapy manufacturing operations on-site.

The role partners with Manufacturing, QC, Engineering, and Facilities to ensure regulatory compliance, drive CAPAs, and lead complex investigations while mentoring team members to support continuous improvement and patient safety.

Qualifications

• Requires strong attention to detail and experience with GMP documentation.
• Experience in viral vector, cell therapy, or biopharma environments.
• Ability to mentor and guide QA staff.

Responsibilities

• Provide quality oversight for viral vector and cell therapy manufacturing operations, ensuring compliance with cGMP, GDP, ISO, and quality system requirements.
• Support manufacturing floor activities through QA presence on the floor, including quality oversight of critical operations and real-time decision making.
• Review and approve Master Batch Records, executed batch records, GMP documents, and supporting production records to support manufacturing execution and batch disposition.
• Perform QA walkthroughs and collaborate with Manufacturing, Quality Control, Engineering, and support groups to identify, investigate, and resolve quality and compliance issues.
• Lead and support complex investigations, deviations, CAPAs, change controls, and other quality system processes using structured problem-solving methodologies.
• Review and approve quality system records and GMP documentation generated by Manufacturing, QC, Material Management, and supporting departments.
• Provide informal leadership, mentoring, and guidance to team members while supporting departmental priorities and continuous improvement initiatives.
• Maintain inspection readiness and ensure ongoing compliance with applicable regulatory requirements and internal quality standards.
• Perform cleanroom activities requiring gowning and support manufacturing operations through direct quality oversight in classified environments.
• Manage multiple priorities simultaneously while maintaining accurate tracking of quality records and driving operational excellence.

Skills

QA oversight

GMP compliance

Investigations

CAPA

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Job description

Quality Assurance Specialist III - Viral Vector (Second Shift)

Location: Houston, Texas – Onsite
Shift: Monday through Friday, 3:00 PM – 11:30 PM

As a Quality Assurance Specialist III - Viral Vector, you will serve as a senior representative of the Quality Assurance organization, ensuring quality and compliance standards are maintained across viral vector, cell therapy, and advanced therapy manufacturing operations. This role partners closely with Manufacturing, Quality Control, Engineering, Facilities, and other support functions to provide quality oversight of production activities, support complex quality investigations, maintain cGMP compliance, and help deliver life-changing therapies to patients. You will also provide informal leadership and guidance within the QA team while taking ownership of complex quality issues and continuous improvement initiatives.

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. This position is eligible for a performance-related bonus program.

What you will do:

• Provide quality oversight for viral vector and cell therapy manufacturing operations, ensuring compliance with cGMP, GDP, ISO, and quality system requirements.
• Support manufacturing floor activities through QA presence on the floor, including quality oversight of critical operations and real-time decision making.
• Review and approve Master Batch Records, executed batch records, GMP documents, and supporting production records to support manufacturing execution and batch disposition.
• Perform QA walkthroughs and collaborate with Manufacturing, Quality Control, Engineering, and support groups to identify, investigate, and resolve quality and compliance issues.
• Lead and support complex investigations, deviations, CAPAs, change controls, and other quality system processes using structured problem-solving methodologies.
• Review and approve quality system records and GMP documentation generated by Manufacturing, QC, Material Management, and supporting departments.
• Provide informal leadership, mentoring, and guidance to team members while supporting departmental priorities and continuous improvement initiatives.
• Maintain inspection readiness and ensure ongoing compliance with applicable regulatory requirements and internal quality standards.
• Perform cleanroom activities requiring gowning and support manufacturing operations through direct quality oversight in classified environments.
• Manage multiple priorities simultaneously while maintaining accurate tracking of quality records and driving operational excellence.

What we are looking for:

• Associate’s or Bachelor’s degree in Life Sciences, Engineering, or a related scientific discipline preferred. Relevant industry experience may be considered in lieu of formal education requirements.
• Experience working in a GMP-regulated biopharmaceutical, biologics, cell therapy, or viral vector manufacturing environment.
• Strong experience reviewing batch records, GMP documentation, and quality system records with exceptional attention to detail.
• Hands-on experience supporting manufacturing operations through QA floor support and cleanroom activities.
• Demonstrated experience managing deviations, investigations, CAPAs, change controls, and quality systems processes.
• Working knowledge of cGMP, GDP, ISO standards, equipment and facility qualification practices, and regulatory requirements.
• Strong communication and collaboration skills with the ability to effectively partner across multiple functional groups.
• Ability to independently resolve complex quality issues and make sound decisions in a fast-paced manufacturing environment.
• Leadership, mentoring, or team coordination experience preferred.
• Strong work ethic, proactive mindset, and commitment to quality, compliance, operational excellence, 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.