Quality Specialist

 For Remediation services in the Quality Assurance area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or Science and three (3) years of experience in quality assurance or systems in the regulated industry. 
• Bilingual: Spanish and English
• Soft Skills: Attention to detail, organization, and writing skills.  
• Shift: Administrative and according to business
• Experience:
  • Quality remediation activities.
  • Rework qualification, document revision, & CAPA Support.
  • Risk assessments, document change management, and compliance improvements. 
  • Electronic quality management systems (eQMS)
  • FDA, GMP & ISO regulations.

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)

• Evaluate and qualify product and process reworks by approved protocols and regulatory requirements.
• Review and revise controlled documents (e.g., SOPs, work instructions, protocols, batch records) as part of remediation efforts.
• Support impact assessments and risk analysis for nonconformances and historical deviations.
• Ensure that changes are documented appropriately, with traceability and justification aligned with quality standards.
• Collaborate with cross-functional teams (Engineering, QA, Manufacturing) to gather required technical inputs.
• Participate in root cause investigations and implement corrective and preventive actions (CAPAs) where applicable.
• Maintain accurate records of all remediation activities and ensure timely completion of assigned tasks.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on 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 the well-being of our resources, while providing our Pharmaceutical, medical device, and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the next piece?