Change Control & Manufacturing Specialist

FITS LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a Scientist for Manufacturing Services within Quality Systems. The role emphasizes GMP-compliant procedures, document control, and cross-functional collaboration to drive process improvements.

The candidate will initiate, revise, and approve procedures, support training, investigate non-conformances, and assist in quarterly reports while maintaining ethical scientific practices in a dynamic lab environment.

Qualifications

• Bachelor's degree with 5+ years as a Scientist in the pharmaceutical or regulated industry.
• Bilingual English and Spanish.
• Experience in Veeva Vault (CDOCs) and Smartsheet.
• Strong technical writing and change control experience.

Responsibilities

• Initiate, revise, and approve manufacturing procedures reflecting current operations.
• Assess process performance by observing floor operations and reviewing data to plan and implement solutions.
• Provide troubleshooting support.
• Assist in generating training materials and delivering training on technical aspects.
• Support establishment of process-monitoring parameters and closure of deviations.
• Responsible for NC/CAPA closure and investigation reporting.

Skills

Bilingual English/Spanish

Project Management

Scientific mindset

Shift flexibility

Education

Bachelor's degree in Science

Tools

Veeva Vault

Smartsheet

Job description

For Manufacturing Services in the Quality Systems area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with five (5)years of experience asa Scientistwithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and according to business needs.
• Experience in:
  • Veeva Vault (CDOCs) & Smartsheet.
  • Technical writing.
  • Change control.

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?