Project Manager - Remediation

 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:
  • Project Management - Quality remediation activities.
  • Rework qualification, document revision, & CAPA.
  • 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)

• Oversee and coordinate product and process rework projects ensuring compliance with approved protocols and regulatory requirements.
• Manage the review and revision of controlled documents (e.g., SOPs, work instructions, protocols, batch records) as part of remediation project deliverables, ensuring timely completion and stakeholder approval.
• Lead impact assessments and risk analysis initiatives for nonconformances and historical deviations, coordinating resources and timelines to meet project objectives.
• Ensure project changes are documented and tracked appropriately, maintaining traceability, justification, and alignment with quality standards throughout the project lifecycle.
• Coordinate and facilitate cross-functional team collaboration (Engineering, QA, Manufacturing) to gather required technical inputs, manage dependencies, and resolve project bottlenecks.
• Oversee root cause investigation projects and manage the implementation of corrective and preventive actions (CAPAs), including resource allocation, timeline management, and progress tracking.
• Maintain comprehensive project documentation of all remediation activities, manage project schedules, ensure milestone completion, and provide regular status updates to stakeholders and leadership.

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?