Change Control Specialist

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

Job summary

FITS LLC in Juncos, Puerto Rico is seeking a qualified Scientist to join our pharmaceutical operations. You will oversee manufacturing procedures, ensure compliance, and drive continuous improvement under strict quality controls.

The role requires bilingual English/Spanish communication, project management skills, and hands-on experience with change control, TrackWise, SAP, and CAPA investigations. Join a team focused on safety, quality, and reliability.

Qualifications

• Must hold a Bachelor's Degree with 4+ years in the pharmaceutical or regulated industry.
• Fluency in English and Spanish is required.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance by observing floor operations and reviewing data; plan and implement solutions.
• Provide troubleshooting support.
• Assist in generation of training materials and delivering training on scientific or technical aspects.
• Support establishment of monitoring parameters and control limits; collect data and assess deviations.
• Ensure timely execution of quarterly process-monitoring reports.
• Triage all Non-conformances within the established goal.
• Author investigative reports.
• Execute corrective actions as needed.
• Manage NC/CAPA closure within goal.
• Monitor and communicate incident trends.
• Review Root Cause Analysis investigations and support trend evaluations.

Skills

Bilingual EN/ES

Project Management

Change Control

Quality Records

Process Validation

Troubleshooting

Education

Bachelor's Degree with 4+ years as Scientist in pharma/regulatory

Tools

TrackWise

SAP

Job description

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: Administrative,asneeded bybusiness.
• 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!