Quality Assurance Specialist III - Viral Vector (Sunday - Thursday 11:00 PM - 8:00 AM)

Lonza•Houston, TX

1d•Onsite

About The Position

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.

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.
Strong work ethic, proactive mindset, and commitment to quality, compliance, operational excellence, and patient safety.

Nice To Haves

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.
Leadership, mentoring, or team coordination experience preferred.

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.