Change Control Specialist- 02

FITS, LLC; Juncos (PR); On-site; USD 65,000 - 85,000; Full time

Job summary

FITS, LLC is seeking a Scientist for Manufacturing Services in Quality Systems in Puerto Rico. Five years of pharmaceutical or regulated industry experience is required, with a Bachelor's degree and an administrative shift.

Responsibilities include initiating procedures, evaluating process performance, and supporting training materials. The role covers change control, process validation, batch records, and investigation/report writing while upholding compliance and timely NC/CAPA closures within

Qualifications

• Bachelor's degree in a relevant field with five years of experience in pharmaceutical or regulated industry.
• Shift: Administrative and based on business needs.
• Experience in Change Control, Compliance, process validation, and batch records.

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Serve as document owner.
• Assess process performance by observing floor operations and reviewing data; implement solutions.
• Assist in generation of training materials and training on scientific/technical aspects.
• Support establishment of process monitoring parameters and control limits; collect data.
• Support timely execution of quarterly process monitoring reports.
• Triage non-conformances within established goals.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within established goals.
• Monitor incident trends and communicate findings.
• Review equipment/system Root Cause Analysis and support trend evaluations.

Skills

Pharma experience

Change Control

Process Validation

Batch Records

Education

Bachelor's degree

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:
  • 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.
• 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!