Quality Specialist

 For Quality Services.

WHAT MAKES YOU A FIT: 

The Technical Part:

• 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.

The Personality Part:     

• 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!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• 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.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?