Quality Applications Specialist - 135

Quality role to support product transfer activities. focused on process validation.  

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's Degree in Engineering with at least three (3) years of experience within the regulated industry. 
• Bilingual (English & Spanish).
• Good communication skills.
• Shift: 1st and according to business needs.
• Experience in: 
  • Sterilization
  • Final Pack
  • Process Validation, Statistical Analysis, Process Failure Mode, and First Time Quality.

The Personality Part:    

• Besides being able to provide guidance, you're able to work independently to solve problems and improve every aspect of the project. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, and you might just be what we’re looking for!

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

• Conduct a compliant validation process for quality information technology systems, producing all required formal validation documentation.
• Coordinate validation‑related activities with clients, programmers/developers, and operating personnel across domestic teams and, when appropriate, global partners.
• Identify current and anticipated requirements for compliant computerized operations and effective methods for establishing and implementing them.  
• Maintaining the procedures, actions, and documentation needed to meet federal and international regulatory standards.
• Report on the status of validation activities to ensure regulatory requirements are fulfilled, and stakeholders remain informed.
• Stay informed on evolving federal and international regulatory requirements, government audit expectations, and emerging techniques relevant to validation and compliance.
• Perform system administration and configuration tasks for quality information technology systems to support validated and compliant system performance.

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?