Deviation Investigator

 For Quality services in the PR01 Plant

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's degree in Engineering or Life Sciences with five (5) + years of experience in leading Deviation Investigations within the pharmaceutical, biotech, medical device, or other regulated manufacturing environment. 
• Experience in: 
  • Conducting and documenting investigations related to deviations, nonconformances, and quality events.
  • Electronic quality systems (Trackwise, Veeva, etc.) 
  • Root cause analysis tools and structured problem solving.

The Personality Part:    

• If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead, then this is the job for you! Sprinkle on a love for the scientific method, teamwork, and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on! 

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

• Lead end to end investigations for deviations and quality events.
• Gather and analyze data, interview personnel, and review documentation to understand event details.
• Apply structured root cause analysis methodologies (e.g., Causal Factor, 5 Whys, Fishbone, Fault Tree,).
• Ensure investigations are completed within required timelines and meet regulatory and internal quality standards.
• Identify true root causes supported by evidence.
• Develop effective CAPA plans that address root causes and prevent recurrence.
• Partner with process owners to ensure CAPA implementation, effectiveness checks, and closure.
• Prepare clear, concise, and compliant investigation reports.
• Ensure documentation meets GMP, and regulatory expectations.
• Maintain high standards of accuracy, clarity, and traceability.
• Work closely with Operations, Quality Assurance, Engineering, Maintenance, and other departments.
• Facilitate investigation meetings and lead cross-functional problem-solving sessions.
   

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?