Quality Engineer - GMP Investigations & CAPA Lead (Contract)

Piper Companies; Raleigh (NC); On-site; USD 228,682,000 - 272,765,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

Job summary

Piper Companies seeks a Quality Engineer to join a leading pharmaceutical manufacturing organization in Raleigh, NC for a 3–6 month contract. The Quality Engineer will lead investigations, partner with plant personnel, and drive timely resolution of quality events in a GMP-regulated environment.

Responsibilities include leading deviations investigations, CAPA root-cause analysis, collaborating with production, engineering, and quality teams, reviewing quality documentation, and supporting

Qualifications

• 3+ years in a quality engineering/quality assurance/manufacturing support role within a regulated environment.
• Hands-on experience conducting investigations within a pharmaceutical, biologics, chemical, or related manufacturing facility.
• Strong understanding of GMP regulations, deviation management, root cause analysis, and CAPA processes.
• Ability to collaborate across functional teams and communicate technical findings to stakeholders.
• Bachelor's degree in Engineering, Chemistry, Biology, or related discipline preferred.

Responsibilities

• Lead and support investigations related to deviations, non-conformances, and quality events in the manufacturing environment.
• Partner with production, engineering, and quality teams to identify root causes and develop CAPAs.
• Perform shop floor assessments and gather technical information to resolve quality issues.
• Review quality documentation and ensure investigations align with GMP requirements and internal procedures.
• Assist with remediation tied to regulatory observations, audit findings, and quality system improvements.

Skills

Quality engineering

CAPA processes

GMP regulations

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related

Job description

Piper Companies seeks a Quality Engineer to join a leading pharmaceutical manufacturing organization in Raleigh, NC for a 3–6 month contract. The Quality Engineer will lead investigations, partner with plant personnel, and drive timely resolution of quality events in a GMP-regulated environment.

Responsibilities include leading deviations investigations, CAPA root-cause analysis, collaborating with production, engineering, and quality teams, reviewing quality documentation, and supporting