Manufacturing Specialist- 11

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

For Manufacturing Services in the Quality Systems a rea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with five (5)years of experience asa Scientistwithin the pharmaceutical or regulated industry.
• Shift: Administrative and according to business needs.
• Experience in:
  • Manufacturing Operations.
  • Continuous improvement methodologies.
  • Troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization.
  • Compliance, and documentation practices for regulated industries.

The Personality Part:

• Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• 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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!