Quality Assurance Specialist II - Viral Vector

Lonza•Houston, TX

11d•Onsite

About The Position

The Quality Assurance Specialist II serves as a representative of the Quality Assurance organization, helping maintain quality and compliance standards across viral vector and advanced therapy manufacturing operations. The role partners with Manufacturing, Quality Control, Engineering, and other support functions to support production activities, maintain cGMP compliance, and help deliver therapies to patients. The position provides quality oversight for viral vector and cell therapy manufacturing, including on-floor support, batch record and GMP documentation review, quality investigations, and other quality system processes. It also involves classified cleanroom work requiring Level 3 gowning (Grade B), maintaining inspection readiness, tracking quality records, and supporting continuous improvement. The role is onsite in Houston, Texas, with a Sunday-through-Thursday schedule from 7:00 AM to 3:30 PM.

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 collaborate effectively 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

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

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, 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.