GMP Quality Engineer - CAPA & Investigation Lead

Zachary Piper Solutions; Raleigh (NC); On-site; USD 103,000 - 131,000; Part time

Benefits offered by this job

Medical Insurance

Dental & Vision

401K

Job summary

Piper Companies seeks a Quality Engineer for a contract role in the Raleigh, NC area. You will investigate deviations, manage CAPA, and drive compliance remediation in a GMP manufacturing environment.

You will partner with production teams, perform root cause analyses, and support readiness for FDA inspections. Strong collaboration and hands-on problem solving are essential for success in this role.

Qualifications

• Experience with GMP-regulated manufacturing environments.
• Hands-on root cause analysis in production.
• Capable of leading CAPA activities and closures.
• Knowledge of FDA regulations and quality systems.
• Experience in chemical/pharma manufacturing preferred.

Responsibilities

• Investigate deviations, nonconformances, and quality events.
• Collaborate with production and leadership to assess processes.
• Lead CAPA activities and ensure timely closure.
• Support remediation from regulatory observations and QA improvements.
• Perform on-site assessments to strengthen compliance and readiness.

Skills

Investigations

CAPA management

Root cause analysis

FDA regulations

GMP/cGMP

Deviation management

Education

Bachelor's degree in Engineering or related field

Job description

Piper Companies seeks a Quality Engineer for a contract role in the Raleigh, NC area. You will investigate deviations, manage CAPA, and drive compliance remediation in a GMP manufacturing environment.

You will partner with production teams, perform root cause analyses, and support readiness for FDA inspections. Strong collaboration and hands-on problem solving are essential for success in this role.