Manufacturing Scientist - Quality Systems & CAPA Lead

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

Job summary

FITS, LLC in Puerto Rico seeks a Scientist for manufacturing services within Quality Systems. The role requires a Bachelor's degree and five years of experience in a pharmaceutical or regulated setting, with responsibilities spanning procedures, CAPA, and continuous improvement.

The candidate will troubleshoot manufacturing issues, monitor process performance, and contribute to training materials while ensuring compliance and documentation practices are upheld across operations.

Qualifications

• Bachelor's degree with five years of experience as a Scientist in the pharmaceutical or regulated industry.
• Experience in Manufacturing Operations.
• Experience in Continuous improvement methodologies.
• Troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization.
• Compliance, and documentation practices for regulated industries.

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.
• 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

Manufacturing operations

Continuous improvement

CAPA (Corrective/Preventive Actions)

Troubleshooting

Documentation and compliance

Education

Bachelor's degree in science

Tools

CAPA process

Job description

FITS, LLC in Puerto Rico seeks a Scientist for manufacturing services within Quality Systems. The role requires a Bachelor's degree and five years of experience in a pharmaceutical or regulated setting, with responsibilities spanning procedures, CAPA, and continuous improvement.

The candidate will troubleshoot manufacturing issues, monitor process performance, and contribute to training materials while ensuring compliance and documentation practices are upheld across operations.