Change Control Specialist

FITS LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a Scientist for Manufacturing Services within the Quality Systems area, focusing on procedural control and process monitoring on site in Juncos.

You will implement procedures, analyze performance, provide troubleshooting, and help train staff on scientific and technical aspects of the process. The role requires bilingual English/Spanish and an administrative shift aligned with business needs.

Qualifications

• Bachelor's Degree with five years of experience as a Scientist in the pharmaceutical or regulated industry.
• Bilingual in English and Spanish.
• Strong Project Management skills.
• Shift: Administrative and according to business needs.
• Experience with Root Cause Analysis, Lean Manufacturing and GDP Practices.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations.
• Assess process performance by observing floor operations and reviewing performance data.
• Provide troubleshooting support and assist in training materials.
• Support establishment of process monitoring parameters and quarterly reports.
• Ensure timely resolution of non-conformances and authoring investigation reports.
• Manage NC/CAPA closure and monitor incident trends.

Skills

Project Management

Bilingual English Spanish

Root Cause Analysis

Lean Manufacturing

GDP Practices

Education

Bachelor's Degree

Tools

Trackwise

VEEVA

MES

Smart Sheet

Power BI

Spotfire

ChatGPT

Copilot

CDOCS

Job description

For Manufacturing Services in the Quality Systems area.

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 and according to business needs.
• Experience in:
  • Root Cause Analysis methodologies.
  • Lean Manufacturing and GDP Practices.
  • Trackwise, VEEVA, MES, Smart Sheet, 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 established goal.
• Monitor and communicate incidents trends.
• 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?