Quality Assurance Specialist II (Viral Vector)

TL;DR

Quality Assurance Specialist II (Viral Vector): Ensuring quality and compliance standards in viral vector and advanced therapy manufacturing with an accent on cGMP compliance and documentation review. Focus on providing on-the-floor quality oversight, resolving compliance issues, and maintaining inspection readiness.

Location: Onsite in Houston, Texas

Company

A global leader in life sciences dedicated to manufacturing the medicines of tomorrow.

What you will do

• Provide quality oversight for viral vector and cell therapy manufacturing, ensuring cGMP and GDP compliance.
• Perform on-the-floor QA activities, including line clearances and critical operations support.
• Review and approve Master Batch Records and GMP documentation to support product disposition.
• Lead investigations, deviations, CAPAs, and change controls using structured problem-solving.
• Conduct cleanroom activities requiring Level 3 gowning (Grade B) to support operations.
• Maintain accurate quality records and support continuous improvement initiatives.

Requirements

• Experience in a GMP-regulated biopharmaceutical, biologics, cell therapy, or viral vector environment.
• Hands-on cleanroom and gowning experience within classified manufacturing environments.
• Proficiency in reviewing GMP documentation and batch records with high attention to detail.
• Knowledge of CAPAs, deviations, and change control processes.
• Associate degree in Life Sciences, Engineering, or a related scientific discipline (preferred).
• Must be based in or able to work onsite in Houston, TX

Culture & Benefits

• Competitive compensation package with performance-related bonuses.
• Comprehensive medical, dental, and vision insurance.
• 401(k) matching plan.
• Life, short-term, and long-term disability insurance.
• Paid time off (PTO) and employee assistance programs.