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Kelly Science, Engineering, Technology & Telecom · Raleigh, North Carolina
Quality Investigator (Contract)
Raleigh, NC
Pay:
$40–$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
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.
Utilize SAP and other quality systems to support documentation and reporting.
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.
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.
Details
| Company | Kelly Science, Engineering, Technology & Telecom |
| Location | Raleigh, North Carolina |
| Type | FULL TIME |
| Niche | Regulatory government associate professionals |