Pharma Quality Engineer II: CAPA & Data-Driven QA

Paladin Labs Inc.; Raleigh (NC); Híbrido; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Paladin Labs Inc. is seeking a Quality Engineer II in Raleigh, NC to interpret and apply regulatory requirements within a cGMP manufacturing setting.

The role provides process and quality engineering support, including statistical analysis and continuous improvement initiatives to ensure the highest product quality for customers. The ideal candidate has 1–5 years in QA or pharmaceutical manufacturing, knowledge of ICH guidelines, and strong communication skills.

Formación

• B.S. Degree in Chemical Engineering preferred; other degrees considered with relevant experience.
• Experience in QA or pharmaceutical manufacturing environment (1-5 years).
• Knowledge of ICH Guidelines (Q7, Q8, Q9, Q10), FDA, EMA, USP, EP, JP.

Responsabilidades

• Interpret and apply applicable regulations and Quality Systems.
• Provide statistical and process support for continuous improvement.
• Lead or participate in CAPA, deviation investigations, and risk analyses.

Conocimientos

Quality systems

Root cause analysis

Six Sigma

Project management

Written communication

English proficiency

Educación

B.S. in Chemical Engineering

Herramientas

Excel

Minitab

Descripción del empleo

Paladin Labs Inc. is seeking a Quality Engineer II in Raleigh, NC to interpret and apply regulatory requirements within a cGMP manufacturing setting.

The role provides process and quality engineering support, including statistical analysis and continuous improvement initiatives to ensure the highest product quality for customers. The ideal candidate has 1–5 years in QA or pharmaceutical manufacturing, knowledge of ICH guidelines, and strong communication skills.