Quality Systems & Process Improvement Specialist

FITS, LLC; Juncos (PR); On-site; USD 95,000 - 125,000; Full time

Job summary

FITS, LLC is seeking a Scientist for Manufacturing Services in Quality Systems in Puerto Rico. The role involves authoring, revising, and approving manufacturing procedures and owning related documents.

You will assess floor operations, review performance data, and implement solutions to improve processes. The position requires a Bachelor's degree with 5+ years in pharma/regulatory environments, and the ability to work administrative shifts as needed.

Qualifications

• Requires a Bachelor's degree with 5+ years as a Scientist in pharma or regulated industry.
• Administrative shift as per business needs; on-site lab environment.

Responsibilities

• Initiate, revise, and approve manufacturing procedures and own documents.
• Assess process performance by floor observations and data reviews; implement solutions.
• Assist in training materials and deliver training on process aspects.
• Support process monitoring data collection and deviation assessments.
• Ensure timely quarterly process monitoring reports.
• Triages non-conformances within goals; author investigation reports.
• Execute corrective actions and manage NC/CAPA closures.
• Monitor incidents trends and review RCA investigations for trends.

Skills

Root Cause Analysis

Lean Manufacturing

GDP Practices

Multitasking

Scientific/technical skills

Process monitoring

Documentation ownership

Education

Bachelor's degree

Tools

Trackwise

VEEVA

MES

Smart Sheet

Power BI

Spotfire

CDOCS

ChatGPT

Copilot

Job description

FITS, LLC is seeking a Scientist for Manufacturing Services in Quality Systems in Puerto Rico. The role involves authoring, revising, and approving manufacturing procedures and owning related documents.

You will assess floor operations, review performance data, and implement solutions to improve processes. The position requires a Bachelor's degree with 5+ years in pharma/regulatory environments, and the ability to work administrative shifts as needed.