Quality Specialist

• Bachelor’s Degree with five (5) years of direct experience as a Quality Specialist.
• Professional in the regulated industry.
• Bilingual (English & Spanish)
• Experience in:

• Aseptic Process Experience.
• Five plus (5+) years as a Quality Specialist in the regulated industry.

• Being self-motivated means that you are curious and anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail, that nothing gets past you. If this sounds like you, and if you commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we’re looking for!

• Provide oversight of aseptic operations, including gowning, material/ equipment transfers, aseptic manipulations, and routine production activities.
• Perform routine walkthroughs of cleanrooms to verify adherence to aseptic techniques, environmental controls, and GMP compliance.
• Review and approve manufacturing batch records, SOPs, and associated quality documentation.
• Support investigations, CAPA, and change controls related to aseptic practices, deviations, and environmental monitoring trends.
• Collaborate with manufacturing, microbiology, and engineering teams to ensure readiness and compliance during media fills, revalidations, and regulatory inspections.
• Participate in continuous improvement initiatives to strengthen aseptic controls and reduce contamination risks.
• Ensure compliance with FDA, EMA, and other global regulatory requirements for aseptic manufacturing.

Flexible & Integrated Technical Services