Change Control & Manufacturing Specialist — Pharma QA

FITS, LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS, LLC is seeking a Scientist to support Manufacturing Services in Quality Systems at our Puerto Rico facility. The role involves creating and updating manufacturing procedures, monitoring process performance, and training team members in technical aspects of the process.

You will work in an administrative shift aligned to business needs, applying regulatory and quality controls across pharmaceutical operations.

Qualifications

• Bachelor's degree with five years of experience as a Scientist in pharmaceutical or regulated industry.
• Shift: Administrative and according to business needs.
• Experience in Veeva Vault (CDOCs) & Smartsheet; Technical writing; Change control.

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.
• Assist in generating training materials and providing training on process science or technical aspects.
• Support establishment of process monitoring parameters and control limits; collect data and assess deviations.
• Ensure timely execution of quarterly process monitoring reports.
• Triaged non-conformances within established goals.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within set timelines.
• Monitor incident trends and communicate findings.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Skills

Veeva Vault CDOCs

Smartsheet

Technical writing

Change control

Education

Bachelor's degree in life sciences

Tools

Veeva Vault (CDOCs)

Smartsheet

Job description

FITS, LLC is seeking a Scientist to support Manufacturing Services in Quality Systems at our Puerto Rico facility. The role involves creating and updating manufacturing procedures, monitoring process performance, and training team members in technical aspects of the process.

You will work in an administrative shift aligned to business needs, applying regulatory and quality controls across pharmaceutical operations.