Quality, Investigator

For Quality services in the Engineering area.

 WHAT MAKES YOU A FIT:  

The Technical Part:

• Bachelor’s Degree in Engineering or Life Sciences & five (5) years of experience in the Pharmaceutical Manufacturing industry. 
• Bilingual (English & Spanish)
• Experience in:
  • Pharmaceutical industry with emphasis on root cause analysis investigations and quality systems.
  • Parenteral manufacturing.
  • Technical writing
  • Cross-functional investigations for manufacturing equipment and utilities failures, environmental excursions, pest control, maintenance systems, human error and other quality events.

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 of 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 Be The Piece?

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

• In a timely manner, lead cross-functional investigations for manufacturing equipment and utilities failures, environmental excursions, pest control, maintenance systems, human error and other quality events.
• Apply structured problem-solving tools (e.g., 5 Whys, Fishbone Diagram, Fault Tree Analysis) to identify true root causes.
• Collaborate with Manufacturing, Quality Control, Engineering, and other departments to gather data and insights.
• Draft clear, concise, and scientifically sound investigation reports in compliance with cGMP and regulatory expectations.
• Negotiate, recommend and track CAPAs to ensure timely and effective implementation.
• Participate in continuous improvement initiatives to reduce recurring deviations and improve engineering processes.
• Supports pre-inspection requests and walkthroughs.
• Support Site and Department’s regulatory inspections and audits.
• Complete responses for audit findings.
• Support Engineering Trainings Programs.
• Revise SOPs and lead, participate in improvements initiatives for the Engineering Department.
• Complete quality records on time: CAPAs, Standalone Actions, Effectiveness Checks, etc.
• Lead Change Controls: Present in local review board and act as change control owner up to change implementation.
• Maintain Quality / Compliance metrics of the Engineering Department, including investigations, and contributes to trend analysis and reporting.

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 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?