Quality Assurance Specialist II - Viral Vector

Lonza•Houston, TX

2d•Onsite

About The Position

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.

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

Nice To Haves

Associates degree in Life Sciences, Engineering, or a related scientific discipline preferred. Relevant industry experience may be considered in lieu of degree requirements.
Knowledge of deviations, CAPAs, change controls, and quality systems processes preferred.
Cell therapy and/or viral vector manufacturing experience preferred.

Responsibilities

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.