Contract Quality Investigator

Quality Investigator (Contract)

Location: Raleigh, NC (Fully onsite role, no remote work options)

Pay: $50/hour

Employment Type: Contract 

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. (no remote work)

• 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.

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