Pharma Quality Systems Specialist - Manufacturing

fitspr; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

FITS seeks a Scientist for Manufacturing Services in Quality Systems, bringing 4+ years in pharma/regulated environments and bilingual English/Spanish. You will own procedures, monitor process performance, and support NC/CAPA closure with hands-on change control and data analysis.

The role requires project management skills, shift flexibility, and collaboration across teams to maintain compliance and drive improvements in manufacturing operations.

Qualifications

• Bachelor's degree with four (4) years of experience as a Scientist in the pharmaceutical or regulated industry.
• Bilingual in English and Spanish.
• Project management skills.
• Shift: Administrative and according to business needs.
• Experience in Change Control processes, with hands-on expertise assessing supplier-related quality records.
• Experience with TrackWise and SAP.
• Non-conformance/CAPA investigation authoring and closure management.
• Process validation protocols, execution, and data analysis.

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions.
• 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

Bilingual English & Spanish

Project management

Change Control

Process monitoring

Data analysis

Education

Bachelor's degree

Tools

TrackWise

SAP

Job description

FITS seeks a Scientist for Manufacturing Services in Quality Systems, bringing 4+ years in pharma/regulated environments and bilingual English/Spanish. You will own procedures, monitor process performance, and support NC/CAPA closure with hands-on change control and data analysis.

The role requires project management skills, shift flexibility, and collaboration across teams to maintain compliance and drive improvements in manufacturing operations.