Deviation Specialist

FITS LLC; Las Piedras (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a qualified Scientist for Manufacturing Services in Quality Systems. The position requires a Bachelor’s degree with 5 years of pharmaceutical/regulatory experience, bilingual English/Spanish, and strong project management skills.

You will initiate and revise manufacturing procedures, assess process performance, provide troubleshooting, and contribute to training material development.

Qualifications

• Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative, as needed.
• 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.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure procedures reflect current operations; serve as document owner.
• Assess process performance by floor observations and data reviews; plan and implement solutions.
• Provide troubleshooting support.
• Assist in generation of training materials and training on scientific/technical aspects.
• Support establishment of process monitoring parameters and control limits; collect data and assess deviations.
• Ensure timely execution of quarterly process monitoring reports.
• Triaging Non-conformances within established goals; author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within established goals; monitor incident trends; review RCA investigations and support trend evaluations.

Skills

Bilingual (English & Spanish)

Project Management

Multitasking

Teamwork

Regulatory/compliance mindset

Education

Bachelor's degree in Science

Tools

TrackWise

VEEVA

MES

Smartsheet

ChatGPT

Copilot

Power BI

Spotfire

CDOCS

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?