Deviation Specialist — Pharma Quality Systems Leader

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

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.