Pharma Change Control & CAPA 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

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.