Operations Quality Engineer — Process & CAPA Lead

Paladin Labs Inc.; Raleigh (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

Par Health is seeking a Quality Engineer to interpret and apply cGMP regulations and Quality Systems, providing Process/Quality Engineering support across the facility to ensure the highest quality products for customers. The role emphasizes statistical analysis and continuous improvement to drive root cause resolution and CAPA effectiveness.

In this position, you will lead quality system activities, support daily QA operations, and contribute to monthly metrics and trending.

Qualifications

• B.S. in Chemical Engineering preferred; other degrees may be considered with relevant experience.
• ICH Guidelines knowledge (Q7–Q10) and related pharma regulations.
• QA experience in a pharmaceutical manufacturing environment is required.

Responsibilities

• Support Deviations, CAPA, and Change Control within the Quality System.
• Assist with Internal Audits, Supplier Quality, and Annual Product Reviews.

Skills

Root cause analysis

Quality system knowledge

Statistical analysis

Problem solving

Communication skills

Team collaboration

Attention to detail

Education

B.S. in Chemical Engineering

Tools

Excel

Minitab

Statistical software

Job description

Par Health is seeking a Quality Engineer to interpret and apply cGMP regulations and Quality Systems, providing Process/Quality Engineering support across the facility to ensure the highest quality products for customers. The role emphasizes statistical analysis and continuous improvement to drive root cause resolution and CAPA effectiveness.

In this position, you will lead quality system activities, support daily QA operations, and contribute to monthly metrics and trending.