Manufacturing Specialist

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

For Manufacturing Services in the Quality Systems area.

WHAT MAKES YOU A FIT:

The Technical Part:

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

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.
• 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.

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!

Are you the next piece?