Senior Quality Engineer, GMP & Process Improvement

Paladin Labs Inc.; Raleigh (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

Paladin Labs Inc. is hiring a Senior Quality Engineer in Raleigh, North Carolina. In this role, you will develop and implement SOPs while supporting regulatory compliance across a cGMP manufacturing facility.

The successful candidate will have at least 5 years of experience in quality assurance within pharmaceutical manufacturing, strong communication skills, and a deep understanding of relevant regulations. Join us to ensure the highest quality products reach our customers.

Qualifications

• Minimum of 5 years' experience in QA/pharmaceutical manufacturing.
• Knowledge of ICH Guidelines, FDA, EMA regulations.
• Strong technical, oral, and written communication skills.

Responsibilities

• Interpret and apply regulatory requirements.
• Develop, implement, and maintain SOPs.
• Provide Process/Quality Engineering support.

Skills

Quality assurance

Regulatory inspections

Statistical process control

Project management

Problem-solving

Education

B.S. degree in Engineering, Science, or a related field

Tools

SPC

FMEA

Six Sigma tools

Job description

Paladin Labs Inc. is hiring a Senior Quality Engineer in Raleigh, North Carolina. In this role, you will develop and implement SOPs while supporting regulatory compliance across a cGMP manufacturing facility.

The successful candidate will have at least 5 years of experience in quality assurance within pharmaceutical manufacturing, strong communication skills, and a deep understanding of relevant regulations. Join us to ensure the highest quality products reach our customers.