Senior Quality Engineer – GMP & Process Improvement

Dormont Manufacturing Co; Raleigh (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Dormont Manufacturing Co is seeking a Sr. Quality Engineer located in Raleigh, NC. The ideal candidate will ensure compliance with applicable regulations and Quality Systems while providing Process and Quality Engineering support. This role includes the management of site audits, statistical analysis, and collaboration with cross-functional teams to facilitate continuous improvement.

Responsibilities include preparing regulatory filings, leading risk analysis activities, and providing training to Quality Department personnel. Candidates should have a B.S. in Engineering or Science and a minimum of 5 years experience in QA/pharmaceutical manufacturing.

Qualifications

• Minimum of 5 years’ experience in a QA/pharmaceutical manufacturing environment.
• Knowledge of regulations (FDA, EMA, USP, etc.).
• Ability to manage multiple projects effectively.

Responsibilities

• Provide input into regulatory filings.
• Analyze trends and initiate investigations.
• Lead corrective and preventive action projects.

Skills

Knowledge of ICH Guidelines

Strong communication skills

Knowledge of Six Sigma Tools

Statistical analysis

Project management

Education

B.S. degree in Engineering or Science

Tools

Excel

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Job description

Dormont Manufacturing Co is seeking a Sr. Quality Engineer located in Raleigh, NC. The ideal candidate will ensure compliance with applicable regulations and Quality Systems while providing Process and Quality Engineering support. This role includes the management of site audits, statistical analysis, and collaboration with cross-functional teams to facilitate continuous improvement.

Responsibilities include preparing regulatory filings, leading risk analysis activities, and providing training to Quality Department personnel. Candidates should have a B.S. in Engineering or Science and a minimum of 5 years experience in QA/pharmaceutical manufacturing.