Pharma Change Control Specialist - Quality & Compliance

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

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