Contract Quality Investigator

Kelly Services; North Carolina; On-site; USD 55,000 - 69,000; Full time

Job summary

Kelly Services is seeking a Quality Investigator for a contract role in Raleigh, NC. The position focuses on investigations of quality events, deviations and CAPA, with phase II OOS investigations and support for audits.

You will analyze metrics, support APRs, and help maintain GMP-compliant documentation. The role is onsite Monday–Friday in Raleigh, with potential to convert to full-time depending on performance and business needs.

Qualifications

• Bachelor's degree in a scientific discipline; relevant experience may substitute.
• 3–5 years of experience in a pharmaceutical, biologics, medical device, or 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.

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.

Skills

Attention to detail

Communication skills

Analytical thinking

Team collaboration

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or related field

Tools

SAP

Job description

Job Description

Quality Investigator (Contract)

Location: Raleigh, NC
Pay: $40–$50/hour
Employment Type: Contract (Open-ended with potential to convert to a full-time position)

We are seeking aQuality 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 experiencein 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 acontract position, there isno defined end date, and the role offers thepotential to convert to a full-time opportunitybased on business needs and performance.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

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About Kelly

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