About the Role
Our consulting firm is placing a driven and detail-oriented QA Specialist II with one of our leading biopharmaceutical clients in Houston, TX. In this role, you will be an integral part of ensuring that manufacturing processes meet the highest quality and regulatory standards. You'll work alongside manufacturing, QC, materials management, and other support functions to uphold cGMP compliance and contribute to the success of a cutting-edge cell and gene therapy product portfolio.
If you thrive in a fast-paced biopharmaceutical environment and are passionate about quality, this is the opportunity for you.
What You'll Do
- Oversee regulatory compliance by confirming that all operations align with ISO/GMP quality system requirements and applicable regulatory guidance.
- Monitor CAPA and deviation programs, ensuring corrective and preventive actions, as well as minor deviations, are properly tracked and closed.
- Conduct QA floor walkthroughs to proactively identify compliance gaps and partner with manufacturing and support teams to implement timely resolutions.
- Provide QA presence during critical manufacturing activities, including in-process monitoring and real-time event management.
- Review and approve GMP documentation, including Master Batch Records (MBRs) and executed records from QC, manufacturing, and materials management teams to support lot disposition.
- Perform buffer/media review and release activities as operationally required.
- Facilitate investigations by applying structured problem-solving methodologies, and assist in driving corrective actions and change controls through to completion.
- Track and maintain quality records, ensuring data integrity and documentation standards are upheld at all times.
- Champion a safety-first mindset within the QA Operations team and across manufacturing functional areas.
What You Bring
- Bachelor's degree in Life Sciences, Engineering, or a related discipline
- 3-5 years of GMP experience in the biologics or pharmaceutical industry
- Working knowledge of equipment/facilities qualifications in GMP and GDP environments
- Familiarity with US and EU regulatory frameworks for biopharmaceutical manufacturing
- Hands-on experience in a biopharmaceutical manufacturing setting
- Background in equipment, facilities, and/or utilities validation activities
- Strong foundation in Good Documentation Practices
Why This Opportunity?
This placement is with a world-class organization at the forefront of cell and gene therapy manufacturing. You'll be joining a collaborative quality team where your contributions make a direct impact on patient outcomes while gaining invaluable experience in a highly specialized and growing therapeutic area.
Interested? Apply today and a member of our team will be in touch to discuss next steps.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, veteran status, or any other characteristic protected by law.
