Deviation & CAPA 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

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.