Quality Investigator

Kelly Science, Engineering, Technology & Telecom; Raleigh (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking a Quality Investigator to join a regulated manufacturing QA team. You will investigate quality events, perform root cause analyses, support CAPA, and contribute to continuous improvement in a GMP environment.

This is an office-based contract role requiring 3–5 years in FDA-regulated manufacturing, SAP proficiency, and strong documentation and communication skills. Potential to convert to full-time based on business needs.

Qualifications

• Bachelor's degree in a scientific discipline preferred or relevant experience.
• 3–5 years of FDA-regulated manufacturing investigation experience.
• Experience with GMP regulations and quality systems.
• Proficiency in SAP and MS Office with strong documentation.
• Excellent written and verbal communication and attention to detail.

Responsibilities

• Investigate quality events, deviations, and exceptions with root cause analysis.
• Develop CAPA recommendations and track closure.
• Support Phase II OOS investigations and audits.
• Analyze quality metrics and generate KPI reports.
• Maintain SOPs and quality documentation; participate in continuous improvement.
• Communicate status updates to leadership and cross-functional teams.

Skills

Root cause analysis

CAPA development

Quality documentation

Data analysis

Communication skills

GMP knowledge

PPE wear

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Engineering

Tools

SAP

Microsoft Office

Job description

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.
• 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.