QA Engineer

For Validation services in the Quality area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Engineering and previous exposure in Validation Life Cycle activities within the Pharmaceutical or Medical Device industry. 
• Shift: Administrative & according to business needs
• Bilingual: (Spanish and English)  
• Experience in:
  • Quality: reviewing validation documentation, procedures and change control.
  • Sampling plans.

The Personality Part:    

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

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

• Knowledge of validation methodologies (IQ, OQ, PQ) and protocols.
• Familiarity with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and FDA/ISO regulatory requirements.
• Proficient in using data analysis tools (Excel, Minitab, or equivalent).
• Strong analytical and problem-solving skills. Excellent technical writing and documentation skills.
• Willingness to work in cleanroom or controlled environments.
• Knowledge of safety procedures and compliance with EHS regulations.
• Ensure timely, thorough and complete execution of all protocols, meeting FDA requirements.
• Ensure that all new and existing protocols are effectively integrated into manufacturing processes. 
• Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
• Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing.
• Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.

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?