Deviation Specialist

FITS LLC; Juncos (PR); On-site; USD 70,000 - 120,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a qualified Scientist for Manufacturing Services within Quality Systems. The role requires a 5-year pharma/regulated industry background and bilingual English/Spanish proficiency.

You will oversee procedures, monitor process performance, provide troubleshooting, and support NC/CAPA closures while ensuring compliance with GDP practices and applicable TrackWise/VEEVA/MES systems.

Qualifications

• Bachelor's Degree with five years' experience as a Scientist in pharma or regulated industry.
• Bilingual English & Spanish proficiency required.
• Strong project management skills.
• Experience with deviations, root cause analysis and risk mitigation.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; own documents.
• Assess process performance by floor observations and data review.
• Provide troubleshooting support and training assistance as needed.
• Support quarterly process monitoring reports and NC/CAPA closure.
• Investigate non-conformances and author investigation reports.

Skills

Bilingual English/Spanish

Project management

Deviation owner

Root cause analysis

Lean manufacturing

GDP practices

Process monitoring

Education

Bachelor's degree in pharmaceutical sciences or related field

Tools

TrackWise

VEEVA

MES

Smartsheet

Power BI

Spotfire

CDOCS

ChatGPT

Copilot

Job description

For Manufacturing Services in the Quality Systems aarea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with five (5)years of experience asa Scientistwithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative,asneeded.
• Experience in:
  • Deviation Owner
  • Root Cause Analysis methodologies.
  • Lean Manufacturing and GDP Practices.
  • TrackWise, VEEVA, MES, Smartsheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms.

The Personality Part:

• Picture yourself in a lab... with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

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

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within the established goal.
• Monitor and communicate incidenttrends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

WHO WE ARE:

We are a Service Provider companydifferent 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 industryclients with top-notch quality talent.We're FITS!

Are you the next piece?