Senior QA Engineer - Regulatory & Quality Excellence

Curium Pharma; Noblesville (IN); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Curium Pharma is seeking a Senior Quality Assurance Engineer to lead quality operations at the Noblesville, IN site. You will investigate exceptions, approve investigations, and drive continuous quality improvement and CAPA actions.

You will partner with cross-functional teams to ensure adherence to US and international guidelines, support regulatory audits, and maintain robust quality systems in a dynamic manufacturing environment.

Formación

• Experience applying RCA tools (5-Whys, Fishbone, TapRoot) to investigations.
• Familiar with US and international regulatory guidelines (FDA, ISO, cGMP).
• Strong knowledge of QA systems, audits, change control, and CAPA processes.

Responsabilidades

• Review and approve Change Control and Quality Documents.
• Maintain compliance with FDA, HC, TGA, ISO, USP, NRC, cGMP guidelines.
• Review and approve validations for equipment, cleaning, and processes.

Conocimientos

RCA techniques

5 Whys

Fishbone analysis

Kepner-Tregoe

TapRooT

Statistical tools

Regulatory compliance

Lean Six Sigma

Educación

Bachelor Degree in Life Sciences or Engineering

Descripción del empleo

Curium Pharma is seeking a Senior Quality Assurance Engineer to lead quality operations at the Noblesville, IN site. You will investigate exceptions, approve investigations, and drive continuous quality improvement and CAPA actions.

You will partner with cross-functional teams to ensure adherence to US and international guidelines, support regulatory audits, and maintain robust quality systems in a dynamic manufacturing environment.