Change Control Specialist- 02

FITS LLC; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a qualified Scientist to support Manufacturing Services in the Quality Systems area. The role requires a Bachelor's degree and 5+ years in pharma/regulatory environments, with bilingual English/Spanish communication and project management skills.

You will initiate and revise procedures, monitor process performance, troubleshoot, and contribute to training material. You will also manage non-conformances, CAPA, and QA investigations to ensure compliant operations.

Qualifications

• Bachelor's degree with five years of experience as a Scientist in pharma or regulated industry.
• Bilingual in English and Spanish.
• Project management skills.
• Shift: Administrative and according to business needs.
• Experience in Change Control & Compliance.
• Experience in process validation protocols and reports.
• Experience in New Product Introduction & Batch Records.

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data.
• 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

Project management

Change control

Process validation

New product introduction

Batch records

Bilingual English/Spanish

Education

Bachelor's degree

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:
  • Change Control & Compliance.
  • Process validation protocols and reports.
  • New Product Introduction & Batch Records.

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?