Quality Engineer II: cGMP, CAPA & Process Improvement

Par Health; North Carolina; On-site; USD 70,000 - 100,000; Full time

Job summary

Par Health is seeking a Quality Engineer to interpret and apply regulations within a cGMP manufacturing setting, providing Process/Quality Engineering support to ensure the highest quality product for customers.

The role applies statistical tools to analyze data, identify root causes, and develop corrective actions for effective problem resolution across projects and continuous improvement initiatives.

Qualifications

• BS in Chemical Engineering preferred; related experience considered.
• Experience in QA or pharmaceutical manufacturing environment (1–5 years).
• Knowledge of ICH Q7/Q8/Q9/Q10, FDA/EMA/USP guidelines.

Responsibilities

• Interpret and apply applicable regulations and quality systems.
• Provide process and quality engineering support to ensure high-quality product delivery.
• Apply statistical tools to analyze data and drive continuous improvement.

Skills

Quality engineering

cGMP

Root cause analysis

FMEA

CAPA

Statistical tools

Excel/Minitab

Problem solving

Data trending

Documentation

Education

BS in Chemical Engineering

Tools

Minitab

Excel

Job description

Par Health is seeking a Quality Engineer to interpret and apply regulations within a cGMP manufacturing setting, providing Process/Quality Engineering support to ensure the highest quality product for customers.

The role applies statistical tools to analyze data, identify root causes, and develop corrective actions for effective problem resolution across projects and continuous improvement initiatives.