Change Control Specialist (Pharma) – Bilingual & QC Focus

FITS LLC; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a qualified Scientist to support Manufacturing Services in the Quality Systems area. The role requires a Bachelor's degree and 5+ years in pharma/regulatory environments, with bilingual English/Spanish communication and project management skills.

You will initiate and revise procedures, monitor process performance, troubleshoot, and contribute to training material. You will also manage non-conformances, CAPA, and QA investigations to ensure compliant operations.

Qualifications

• Bachelor's degree with five years of experience as a Scientist in pharma or regulated industry.
• Bilingual in English and Spanish.
• Project management skills.
• Shift: Administrative and according to business needs.
• Experience in Change Control & Compliance.
• Experience in process validation protocols and reports.
• Experience in New Product Introduction & Batch Records.

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Skills

Project management

Change control

Process validation

New product introduction

Batch records

Bilingual English/Spanish

Education

Bachelor's degree

Job description

FITS LLC in Puerto Rico seeks a qualified Scientist to support Manufacturing Services in the Quality Systems area. The role requires a Bachelor's degree and 5+ years in pharma/regulatory environments, with bilingual English/Spanish communication and project management skills.

You will initiate and revise procedures, monitor process performance, troubleshoot, and contribute to training material. You will also manage non-conformances, CAPA, and QA investigations to ensure compliant operations.