Manufacturing Quality Systems Specialist - Process & CAPA

fitspr; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS PR manufactures services in the Quality Systems area and seeks a Scientist with pharma experience in Puerto Rico. The role requires bilingual English/Spanish communication, project management, and strong data-driven problem solving to improve processes on the floor.

You will own procedures, analyze performance, provide troubleshooting, and help train staff while ensuring NC/CAPA closure and timely reports in a regulated environment.

Qualifications

• Bachelor's degree with five years of experience in pharma or regulated industry.
• Bilingual in English and Spanish.
• PM skills and shift flexibility.
• Experience with quality systems and manufacturing control.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; act as document owner.
• Assess process performance and implement solutions based on data.
• Provide troubleshooting support.
• Assist in generating training materials and deliver training when needed.
• Support process monitoring parameters and control limits; collect data.
• Ensure timely execution of quarterly process-monitoring reports.
• Triage non-conformances within goals; author investigation reports.
• Execute corrective actions and manage NC/CAPA closure.
• Monitor incidents trends and review root cause investigations.

Skills

Bilingual English/Spanish

Project management

Root cause analysis

Lean manufacturing

GDP practices

TrackWise

VEEVA

MES

Power BI

Spotfire

SmartSheet

ChatGPT

Copilot

CDOCS

Education

Bachelor's degree

Tools

TrackWise

VEEVA

MES

SmartSheet

Power BI

Spotfire

CDOCS

Job description

FITS PR manufactures services in the Quality Systems area and seeks a Scientist with pharma experience in Puerto Rico. The role requires bilingual English/Spanish communication, project management, and strong data-driven problem solving to improve processes on the floor.

You will own procedures, analyze performance, provide troubleshooting, and help train staff while ensuring NC/CAPA closure and timely reports in a regulated environment.