Senior Analytical Quality Scientist - GMP Method Validation

Orano Med, LLC.

Plano, TX

JOB DETAILS
SKILLS
Analysis Skills, Analytical Development, Drug Products, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Manufacturing, Product Testing, Quality Assurance, Quality Assurance Methodology, Quality Control, Regulatory Compliance, Test Plan/Schedule
LOCATION
Plano, TX
POSTED
2 days ago

Orano Med LLC in Plano, TX, is seeking a Quality Scientist to ensure the integrity and regulatory compliance of analytical methods for drug product testing from development through Phase 2 manufacturing. You will lead investigations, CAPAs, method qualification, validation, and transfer in line with FDA/EMA guidelines.The role requires strong GMP knowledge, meticulous data translation, and collaboration with QC, Analytical Development, Manufacturing, and QA teams to deliver robust data and#J-18808-Ljbffr

About the Company

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Orano Med, LLC.