Change Control & Manufacturing Specialist - Quality Systems

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

Job summary

FITS LLC in Puerto Rico is seeking a Scientist for Manufacturing Services within Quality Systems. The role emphasizes GMP-compliant procedures, document control, and cross-functional collaboration to drive process improvements.

The candidate will initiate, revise, and approve procedures, support training, investigate non-conformances, and assist in quarterly reports while maintaining ethical scientific practices in a dynamic lab environment.

Qualifications

• Bachelor's degree with 5+ years as a Scientist in the pharmaceutical or regulated industry.
• Bilingual English and Spanish.
• Experience in Veeva Vault (CDOCs) and Smartsheet.
• Strong technical writing and change control experience.

Responsibilities

• Initiate, revise, and approve manufacturing procedures reflecting current operations.
• Assess process performance by observing floor operations and reviewing data to plan and implement solutions.
• Provide troubleshooting support.
• Assist in generating training materials and delivering training on technical aspects.
• Support establishment of process-monitoring parameters and closure of deviations.
• Responsible for NC/CAPA closure and investigation reporting.

Skills

Bilingual English/Spanish

Project Management

Scientific mindset

Shift flexibility

Education

Bachelor's degree in Science

Tools

Veeva Vault

Smartsheet

Job description

FITS LLC in Puerto Rico is seeking a Scientist for Manufacturing Services within Quality Systems. The role emphasizes GMP-compliant procedures, document control, and cross-functional collaboration to drive process improvements.

The candidate will initiate, revise, and approve procedures, support training, investigate non-conformances, and assist in quarterly reports while maintaining ethical scientific practices in a dynamic lab environment.