Remote Supplier Change Control Lead

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

Job summary

FITS LLC in Puerto Rico is seeking a Quality Systems specialist to own supplier change control within a biopharmaceutical manufacturing setting. You will assess changes to raw materials or components and ensure documentation and implementation are completed.

This remote role requires on-site audits as needed. You will track change controls in TrackWise and SAP, triage non-conformances, and drive CAPA closures. Fluency in English and Spanish and project management skills are required.

Qualifications

• Bachelor's degree in a science field with 4+ years in pharma or regulated industry.
• Fluent in English and Spanish.
• PM skills and experience with change control.

Responsibilities

• Own supplier-related change controls from initiation through closure.
• Assess supplier change notifications and quality records for impact on materials and product quality.
• Initiate, revise, and approve manufacturing procedures and raw material documentation affected by supplier changes.
• Track and document change control activities in TrackWise and SAP.
• Triage supplier-related non-conformances within established goals.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within established goals.
• Monitor supplier incident trends and assist in training materials related to changes.

Skills

Project management

Bilingual English/Spanish

Quality systems

Change control

Education

Bachelor's degree in science

Tools

TrackWise

SAP

Job description

FITS LLC in Puerto Rico is seeking a Quality Systems specialist to own supplier change control within a biopharmaceutical manufacturing setting. You will assess changes to raw materials or components and ensure documentation and implementation are completed.

This remote role requires on-site audits as needed. You will track change controls in TrackWise and SAP, triage non-conformances, and drive CAPA closures. Fluency in English and Spanish and project management skills are required.