Senior QA Specialist — GMP Compliance & Validation

ProQuality Network; Northern (KY); Hybrid; USD 75,000 - 110,000; Full time

Job summary

ProQuality Network is seeking a skilled Quality Assurance Specialist to support GMP-compliant manufacturing and QA programs. You will oversee documents, validate processes, and act as SME across multiple functions to ensure regulatory alignment.

The role focuses on investigations, CAPA, risk assessments, and change controls, with strong emphasis on cross-functional collaboration and adherence to quality systems.

Qualifications

• Master’s degree with 3 years of directly related experience, or a relevant alternative degree with extended experience.
• Bachelor’s degree with 5 years of directly related experience.
• Associate’s degree with 10 years of directly related experience.
• High school diploma / GED with 12 years of directly related experience.

Responsibilities

• Review and approve Master Production Records (MPs), work orders, and other controlled documents.
• Approve process validation protocols and reports for manufacturing processes.
• Serve as QA representative on incident triage teams and New Product Introduction (NPI) projects.
• Review and approve Environmental Characterization reports and release sanitary utility systems.
• Lead investigations, audits, and maintain site quality program procedures.
• Review and approve risk assessments, nonconformance (NC) investigations, CAPA records, and change controls.
• Support automation, facilities, environmental programs, and respond to EMS/BMS alarms.
• Provide lot disposition and authorize product release for shipment.

Skills

QA processes

GMP audits

Regulatory interface

Project management

Communication skills

MS Office

Education

Master's degree in a related field

Bachelor's degree in a related field

Associate’s degree

High school diploma

Job description

ProQuality Network is seeking a skilled Quality Assurance Specialist to support GMP-compliant manufacturing and QA programs. You will oversee documents, validate processes, and act as SME across multiple functions to ensure regulatory alignment.

The role focuses on investigations, CAPA, risk assessments, and change controls, with strong emphasis on cross-functional collaboration and adherence to quality systems.