Bilingual Change Control Specialist — Quality & Compliance

FITS LLC; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

FITS LLC in Juncos, Puerto Rico is seeking a qualified Scientist to join our pharmaceutical operations. You will oversee manufacturing procedures, ensure compliance, and drive continuous improvement under strict quality controls.

The role requires bilingual English/Spanish communication, project management skills, and hands-on experience with change control, TrackWise, SAP, and CAPA investigations. Join a team focused on safety, quality, and reliability.

Qualifications

• Must hold a Bachelor's Degree with 4+ years in the pharmaceutical or regulated industry.
• Fluency in English and Spanish is required.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance by observing floor operations and reviewing data; plan and implement solutions.
• Provide troubleshooting support.
• Assist in generation of training materials and delivering training on scientific or technical aspects.
• Support establishment of monitoring parameters and control limits; collect data and assess deviations.
• Ensure timely execution of quarterly process-monitoring reports.
• Triage all Non-conformances within the established goal.
• Author investigative reports.
• Execute corrective actions as needed.
• Manage NC/CAPA closure within goal.
• Monitor and communicate incident trends.
• Review Root Cause Analysis investigations and support trend evaluations.

Skills

Bilingual EN/ES

Project Management

Change Control

Quality Records

Process Validation

Troubleshooting

Education

Bachelor's Degree with 4+ years as Scientist in pharma/regulatory

Tools

TrackWise

SAP

Job description

FITS LLC in Juncos, Puerto Rico is seeking a qualified Scientist to join our pharmaceutical operations. You will oversee manufacturing procedures, ensure compliance, and drive continuous improvement under strict quality controls.

The role requires bilingual English/Spanish communication, project management skills, and hands-on experience with change control, TrackWise, SAP, and CAPA investigations. Join a team focused on safety, quality, and reliability.