Regulated QA Specialist — GMP Compliance & Validation

ProQuality Network; Coffeyville (KS); Hybrid; USD 90,000 - 125,000; Full time

Job summary

ProQuality Network seeks a Specialist QA (Regulated Industry) for a one-year contract to provide quality oversight across manufacturing, validation, change control, and site quality systems in a regulated environment. This role supports our client’s Quality Assurance program and ensures compliance with cGMP and regulatory expectations.

The candidate will collaborate cross-functionally to support manufacturing operations, NPI initiatives, validation activities, and facility programs, driving

Qualifications

• Master’s degree with 2 years of directly related experience or
• Bachelor’s degree with 4 years of directly related experience or
• Associate degree with 8 years of directly related experience or
• High School Diploma/GED with 10 years of directly related experience

Responsibilities

• Review and approve Product Master Plans (MPs).
• Review and approve process validation protocols and reports, including PPQ activities.
• Serve as Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Authorize release of sanitary utility systems.
• Review and approve planned incidents.
• Lead deviation investigations and support CAPA development.
• Lead and participate in site audits.
• Own and maintain site quality program procedures.
• Act as QA Manager designee on the local Change Control Review Board (CCRB).
• Review and approve risk assessments.
• Support Automation, Commissioning & Qualification (C&Q), PPQ, and FAT activities.
• Support facilities and environmental monitoring programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Review and approve Nonconformance (NC) investigations and CAPA records.
• Review and approve change control records.
• Perform lot disposition and authorize product release for shipment.

Skills

Project management

Cross-functional

Leadership

QA/QAL

Regulatory knowledge

Root cause analysis

CAPA

Documentation review

FAT/PPQ

GxP compliance

Data trending

MS Office

Communication

Team collaboration

Education

Master’s degree in related field

Bachelor’s degree in related field

Associate degree

High School Diploma/GED

Tools

None

Job description

ProQuality Network seeks a Specialist QA (Regulated Industry) for a one-year contract to provide quality oversight across manufacturing, validation, change control, and site quality systems in a regulated environment. This role supports our client’s Quality Assurance program and ensures compliance with cGMP and regulatory expectations.

The candidate will collaborate cross-functionally to support manufacturing operations, NPI initiatives, validation activities, and facility programs, driving