GMP Quality Engineer: CAPA & Compliance Investigator

ZP Group; Raleigh (NC); On-site; USD 103,000 - 131,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Sick leave

401K

Job summary

Piper Companies is seeking a Quality Engineer for a contract role in the Raleigh, NC area to focus on investigations, CAPA execution, and compliance remediation within a GMP manufacturing environment.

The role requires strong root cause analysis skills, hands-on problem solving with operations teams, and a solid understanding of FDA/cGMP frameworks to strengthen inspection readiness and regulatory alignment. Position is on-site in Raleigh.

Qualifications

• Bachelor's degree in a technical field required.
• 5+ years in GMP-regulated manufacturing with investigations and CAPA.
• Strong knowledge of FDA regulations and deviation management.

Responsibilities

• Conduct investigations of deviations and quality events to determine root cause and product impact.
• Collaborate with production personnel and plant leadership to evaluate processes and address quality concerns.
• Lead CAPA activities and ensure timely closure per regulatory expectations.
• Support remediation initiatives from regulatory observations and quality system improvements.
• Perform on-site assessments to strengthen compliance and inspection readiness.

Skills

CAPA management

Root cause analysis

GMP manufacturing

Investigations

Education

Bachelor's degree in Engineering/ Chemistry/ QA/ Manufacturing/ Life Sciences

Job description

Piper Companies is seeking a Quality Engineer for a contract role in the Raleigh, NC area to focus on investigations, CAPA execution, and compliance remediation within a GMP manufacturing environment.

The role requires strong root cause analysis skills, hands-on problem solving with operations teams, and a solid understanding of FDA/cGMP frameworks to strengthen inspection readiness and regulatory alignment. Position is on-site in Raleigh.