Quality Engineer - APRR & GMP Compliance (Data-Driven)

Mindlance; Rocky Mount (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Mindlance is seeking a Quality Engineer in Rocky Mount, NC, for an 18-month position focused on writing Annual Product Record Review reports in compliance with regulatory requirements.

The role demands strong analytical skills and the ability to manage multiple projects effectively. Candidates should have a Bachelor's degree and experience in a regulated environment, alongside proficiency in tools like Trackwise and Empower LIMS.

Qualifications

• 2+ years in a GMP FDA regulated environment.
• Experience in Quality Engineering or Regulatory Affairs.
• Familiarity with Quality Management standards.

Responsibilities

• Write Annual Product Record Review reports according to schedules.
• Analyze data trends to improve processes.
• Communicate effectively with clients and suppliers.

Skills

Strong analytical skills

Knowledge of regulatory requirements

Strong organizational skills

Technical writing skills

Communication skills

Computer proficiency in MS Office

Education

Bachelors Degree in relevant field

Tools

Trackwise (ER / LIR)

Empower LIMS System

Job description

Mindlance is seeking a Quality Engineer in Rocky Mount, NC, for an 18-month position focused on writing Annual Product Record Review reports in compliance with regulatory requirements.

The role demands strong analytical skills and the ability to manage multiple projects effectively. Candidates should have a Bachelor's degree and experience in a regulated environment, alongside proficiency in tools like Trackwise and Empower LIMS.