GMP Quality Systems Specialist - Facilities & Engineering

ProQuality Network; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network is seeking a Facilities & Engineering Quality Systems Specialist to support GMP quality systems within a pharmaceutical manufacturing environment. You will partner with Facilities & Engineering and Quality teams to manage deviations, CAPAs, change controls, and controlled documentation.

The role emphasizes hands-on work across engineering, quality, and regulatory functions, ensuring inspection-ready records and effective electronic forms.

Qualifications

• Bachelor's, Master's, or Doctorate in Engineering or related technical field with 2+ years of pharmaceutical experience.
• Strong knowledge of Quality Systems: Deviations, CAPA management, Change Controls, and controlled documentation.
• Experience in the pharmaceutical manufacturing industry and regulatory compliance.
• Understanding of pest control programs within a regulated environment.
• Excellent organizational, communication, and problem-solving skills.

Responsibilities

• Provide primary support for Quality Systems activities related to Facilities & Engineering.
• Investigate and document deviations from procedures, specs, or requirements per SOPs.
• Partner with stakeholders to develop, monitor, and close CAPAs on time.
• Ensure records are complete, accurate, compliant, and inspection-ready.
• Support electronic forms and workflows for quality and facilities systems.
• Assist with pest control program management and related documentation.

Skills

Quality Systems

Deviations

CAPA management

Change Controls

Controlled documentation

Pest control program

Facilities engineering

GMP compliance

Education

Bachelor's degree in Engineering or related field

Master's degree

Doctorate degree

Tools

Electronic forms systems

Quality management software

Job description

ProQuality Network is seeking a Facilities & Engineering Quality Systems Specialist to support GMP quality systems within a pharmaceutical manufacturing environment. You will partner with Facilities & Engineering and Quality teams to manage deviations, CAPAs, change controls, and controlled documentation.

The role emphasizes hands-on work across engineering, quality, and regulatory functions, ensuring inspection-ready records and effective electronic forms.