Quality Investigation & CAPA Consultant

Piper Companies; Raleigh (NC); On-site; USD 117,000 - 138,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401K

Job summary

Piper Companies seeks a Quality Investigation & CAPA Consultant to join a leading pharmaceutical manufacturing organization for an onsite contract in Raleigh, NC. The role partners with manufacturing and quality teams to investigate deviations, drive corrective actions, and strengthen compliance across the site.

Responsibilities include leading complex investigations, collaborating with production, engineering, and quality teams to identify root causes, develop CAPAs, and reduce backlogs while

Qualifications

• 5+ years of experience supporting quality investigations, deviations, and CAPA activities in a regulated manufacturing environment.
• Strong knowledge of GMP requirements and FDA-regulated pharmaceutical or chemical manufacturing operations.
• Hands-on experience working in production facilities and collaborating with cross-functional plant personnel.
• Proven ability to perform root cause analysis and drive effective remediation strategies.

Responsibilities

• Lead and support complex deviation, exception, and nonconformance investigations within a GMP-regulated manufacturing environment.
• Collaborate with production, engineering, and quality teams to identify root causes and develop CAPAs.
• Conduct on-the-floor assessments and gather operational data to support investigations.
• Review quality records and remediation activities to ensure FDA compliance and internal quality standards.
• Assist site leadership with reducing investigation backlogs and improving quality system performance.

Skills

Root cause analysis

CAPA implementation

Deviation investigations

GMP knowledge

Job description

Piper Companies is seeking a Quality Investigation & CAPA Consultant to join a leading pharmaceutical manufacturing organization for an onsite contract position located in Raleigh, NC. The Quality Investigation & CAPA Consultant will support a critical remediation initiative by partnering with manufacturing and quality teams to investigate deviations, drive corrective actions, and strengthen compliance efforts across the site.

Responsibilities of the Quality Investigation & CAPA Consultant include:

• Lead and support complex deviation, exception, and nonconformance investigations within a GMP-regulated manufacturing environment.
• Collaborate directly with production, engineering, and quality teams to identify root causes and develop effective corrective and preventive actions (CAPAs).
• Conduct on-the-floor assessments and gather operational data to support timely and thorough investigations.
• Review existing quality records and remediation activities to ensure compliance with FDA regulations and internal quality standards.
• Assist site leadership with reducing investigation backlogs and improving overall quality system performance.

Qualifications for the Quality Investigation & CAPA Consultant include:

• 5+ years of experience supporting quality investigations, deviations, and CAPA activities within a regulated manufacturing environment.
• Strong knowledge of GMP requirements and FDA-regulated pharmaceutical or chemical manufacturing operations.
• Hands-on experience working directly in production facilities and partnering with cross-functional plant personnel.
• Proven ability to perform root cause analysis and drive effective remediation strategies.
• Experience within pharmaceutical, biotechnology, specialty chemical, enzyme, or related process manufacturing industries preferred.

Compensation for the Quality Investigation & CAPA Consultant:

Salary Range: $85-$100/hr (USD)

Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K.

This job opens for applications on 9/1/26. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: quality assurance, GMP, CAPA, deviation investigations, root cause analysis, FDA compliance, pharmaceutical manufacturing, quality systems, remediation, audit readiness, corrective actions, preventive actions, manufacturing quality, compliance investigations, nonconformance management, quality consulting, regulatory compliance, plant operations, process improvement, quality remediation, validation, quality management systems, biotechnology manufacturing, chemical manufacturing, inspection readiness, quality operations, documentation review, risk assessment, continuous improvement, FDA audit support.

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