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Curium Pharma · 13 hours ago

(Contractor) Quality Assurance Engineer

Noblesville

Full-time, Contract

Onsite

Mid Level

3+ years exp

Curium Pharma is the world’s largest nuclear medicine company, developing and distributing radiopharmaceutical products. The Contractor Quality Assurance Engineer is responsible for supporting the Quality organization in investigations, change management, and maintaining GMP compliance.

Pharmaceutical

Responsibilities

Identify and implement Corrective Actions Investigate Exceptions (Deviations)

Generate or review Change Controls for Batch Records, Standard Operating Procedures, Standard Test Methods, Specifications, Data Sheets, etc

Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects

Perform analysis of data in support of investigations, cost savings, continuous improvement initiatives Work with radioactive materials

Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP’s

Maintain current knowledge of US and international quality regulations

Author or perform peer review of annual product quality reviews

Provide support for regulatory agency (i.e. FDA, HC, TGA, EU, etc.) on-site audits, as required

Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)