Pharma Manufacturing & Quality Systems Specialist

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

Job summary

FITS LLC is seeking a Manufacturing Scientist for the Quality Systems area in Puerto Rico. The role emphasizes initiating, revising, and approving manufacturing procedures, ensuring current operations align with regulatory expectations.

You will analyze process performance, provide troubleshooting, and help develop training materials while supporting data collection for process monitoring and quarterly reports. Fluency in English and Spanish plus project management skills are essential.

Qualifications

• Bachelor's degree required with 5+ years in pharma or regulated environments.
• Bilingual in English and Spanish; strong communication skills.
• Experience with manufacturing procedures and regulatory documentation.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; own documents.
• Assess process performance via floor observations and data reviews.
• Provide troubleshooting support.
• Assist in creating training materials on scientific/technical aspects.
• Support process-monitoring data collection and deviation assessment.
• Ensure timely execution of quarterly process-monitoring reports.
• Triaging non-conformances within goals; authoring investigation reports.
• Execute corrective actions and CAPA closures.
• Monitor incident trends and support root-cause trend evaluations.
• Review Root Cause Analysis investigations and support trend evaluations.

Skills

Project Management

Root Cause Analysis

Lean Manufacturing

GDP Practices

Bilingual (English/Spanish)

Education

Bachelor's Degree

Tools

Trackwise

VEEVA

MES

Smart Sheet

Power BI

Spotfire

CDOCS

ChatGPT

Copilot

Process monitoring platforms

Job description

FITS LLC is seeking a Manufacturing Scientist for the Quality Systems area in Puerto Rico. The role emphasizes initiating, revising, and approving manufacturing procedures, ensuring current operations align with regulatory expectations.

You will analyze process performance, provide troubleshooting, and help develop training materials while supporting data collection for process monitoring and quarterly reports. Fluency in English and Spanish plus project management skills are essential.