GMP Quality Engineer: CAPA & Investigation Lead

Piper Companies; Raleigh (NC); On-site; USD 103,000 - 131,000; Full time

Job summary

Piper Companies is seeking a Quality Engineer for a contract engagement in the Raleigh, NC area. The role focuses on quality investigations, CAPA execution, and compliance remediation within a GMP manufacturing environment to strengthen inspection readiness and FDA compliance initiatives.

The successful candidate will collaborate with production and plant leadership, perform root cause analyses, and drive CAPA closure to meet regulatory expectations in a dynamic manufacturing setting.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Quality Assurance, Manufacturing, Life Sciences, or related field.
• 5+ years in GMP‑regulated manufacturing with investigations and CAPA.
• Hands‑on root cause analysis in manufacturing facilities with operations collaboration.
• Knowledge of FDA regulations, cGMP, quality systems, and deviation management processes.

Responsibilities

• Conduct investigations of deviations, nonconformances, and quality events to determine root cause and product impact within GMP manufacturing operations.
• Partner with production personnel and plant leadership to gather data, evaluate processes, and assess manufacturing‑related quality concerns.
• Lead and author CAPA activities, ensuring timely closure and alignment with regulatory expectations.
• Support remediation initiatives stemming from regulatory observations and quality system improvements.
• Perform on‑site assessments of manufacturing processes, equipment, and operational controls to strengthen compliance and inspection readiness.

Skills

Investigations

CAPA management

Root cause analysis

GMP / cGMP

Deviation management

Regulatory compliance

Education

Bachelor's degree in Engineering/Science

Job description

Piper Companies is seeking a Quality Engineer for a contract engagement in the Raleigh, NC area. The role focuses on quality investigations, CAPA execution, and compliance remediation within a GMP manufacturing environment to strengthen inspection readiness and FDA compliance initiatives.

The successful candidate will collaborate with production and plant leadership, perform root cause analyses, and drive CAPA closure to meet regulatory expectations in a dynamic manufacturing setting.