Onsite Contract Quality Investigator: GMP & CAPA Focus

Mykelly; Raleigh (NC); On-site; USD 57,000 - 81,000; Full time

Job summary

Mykelly in Raleigh, NC is seeking a Quality Investigator for an onsite contract role. You will investigate quality events, perform CAPA, and support audits within a regulated manufacturing environment.

You will collaborate with Manufacturing, Quality, Engineering, and Supply Chain to drive continuous improvement and ensure GMP compliance. This contract position offers potential to convert to full-time based on business needs.

Qualifications

• 3–5 years of experience in a pharmaceutical/regulated manufacturing environment.
• Experience conducting investigations, root cause analysis, CAPA development, and quality documentation.
• Knowledge of GMP regulations and quality systems.
• Proficiency with Microsoft Office; SAP experience is a plus.

Responsibilities

• Conduct investigations for quality events, deviations, and exceptions with root cause and CAPA recommendations.
• Perform Phase II OOS investigations.
• Support regulatory audits by preparing documentation and assisting audit activities.
• Analyze quality metrics and trends, including KPI reporting and data analysis.
• Assist with APRs and quality management reporting.
• Revise and maintain SOPs and quality documentation as needed.

Skills

Investigations

Root Cause Analysis

CAPA

Quality Documentation

Data Analysis

Education

Bachelors in a relevant science

Tools

SAP

Microsoft Office

Job description

Mykelly in Raleigh, NC is seeking a Quality Investigator for an onsite contract role. You will investigate quality events, perform CAPA, and support audits within a regulated manufacturing environment.

You will collaborate with Manufacturing, Quality, Engineering, and Supply Chain to drive continuous improvement and ensure GMP compliance. This contract position offers potential to convert to full-time based on business needs.