Quality Assurance Leader, GMP & Medical Devices

ProQualityNetwork; Columbus (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

ProQualityNetwork seeks a Quality Assurance Specialist to oversee GMP-compliant facility design, installation, commissioning, qualification, and process validation. The role includes supporting QMS implementation and continuous improvement, ensuring compliant manufacturing operations, technology transfers, and site growth.

The ideal candidate demonstrates critical thinking, sound judgment, and a commitment to GMP. Immediate onsite availability in Ohio is required.

Qualifications

• Must be able to work onsite in regulated manufacturing.
• Strong analytical and decision-making skills in GMP environments.
• Immediate availability and Ohio residency required.

Responsibilities

• Provide quality oversight for facility and equipment design, installation, commissioning, qualification, and process validation.
• Support development and continuous improvement of Quality Management Systems (QMS).
• Guide site partners to maintain compliant commercial operations and support technology transfers.
• Assist with deviation management, change control, and review/approval of validation docs and SOPs.
• Support creation of electronic batch records and batch disposition activities.
• Evaluate compliance issues and recommend actions to maintain GMP compliance.

Skills

Quality oversight

Critical thinking

Problem solving

GMP compliance

Tools

Quality Management System (QMS)

Job description

ProQualityNetwork seeks a Quality Assurance Specialist to oversee GMP-compliant facility design, installation, commissioning, qualification, and process validation. The role includes supporting QMS implementation and continuous improvement, ensuring compliant manufacturing operations, technology transfers, and site growth.

The ideal candidate demonstrates critical thinking, sound judgment, and a commitment to GMP. Immediate onsite availability in Ohio is required.