Contract Quality Investigator

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

Quality Investigator (Contract)

Location: Raleigh, NC (Fully onsite role, no remote work options) Pay: $50/hour Employment Type: Contract (Open-ended with potential to convert to a full-time position)

We are seeking a Quality Investigator to join a growing Quality Assurance team supporting a regulated manufacturing environment. This individual contributor role partners cross-functionally with Manufacturing, Quality, Engineering, and Supply Chain to investigate quality events, drive compliance initiatives, and support continuous improvement efforts.

Key Responsibilities

• Conduct investigations for quality events, deviations, and exceptions, including root cause analysis and CAPA recommendations.
• Perform Phase II Out-of-Specification (OOS) investigations.
• Support internal and external regulatory audits by preparing documentation and assisting audit activities.
• Analyze quality metrics and trends, including KPI reporting and data analysis.
• Assist with Annual Product Reviews (APRs) and quality management reporting.
• Revise and maintain SOPs and quality documentation as needed.
• Participate in continuous improvement initiatives, Kaizen events, and GEMBA walks.
• Track investigation progress and communicate status updates to leadership.
• Ensure compliance with GMPs, SOPs, and applicable regulatory requirements.
• Utilize SAP and other quality systems to support documentation and reporting.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or another scientific discipline preferred (relevant experience may be considered in lieu of a degree).
• 3–5 years of experience in a pharmaceutical, biologics, medical device, or other FDA-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.
• Strong written and verbal communication skills with excellent attention to detail and organizational skills.

Work Environment

• Monday–Friday, onsite in Raleigh, NC.
• Office-based with regular interaction in manufacturing, laboratory, warehouse, and cleanroom environments.
• Must be able to wear required PPE and occasionally lift up to 40 lbs.
• Occasional weekend work may be required based on business needs.

This is an excellent opportunity for a quality professional looking to gain experience with a leading regulated manufacturer. While this is a contract position, there is no defined end date, and the role offers the potential to convert to a full-time opportunity based on business needs and performance.