Senior Quality Investigation Lead - GMP & CAPA

Insight Global (United States); Athens (GA); On-site; USD 110,000 - 150,000; Full time

Job summary

Insight Global is seeking a Senior Quality Investigation Specialist to support a GMP pharmaceutical site by reviewing, overseeing, and approving nonconformance and deviation investigations. The role focuses on drafting investigations as needed while ensuring high-quality reviews of root-cause analyses and CAPA effectiveness.

You will challenge root-cause conclusions, guide investigation owners, and drive timely, compliant closures in a 24/7 manufacturing environment.

Qualifications

• 5+ years of pharmaceutical GMP experience with deviation/nonconformance investigations.
• Experience reviewing investigations, not only writing them.
• Strong root-cause analysis and CAPA knowledge.
• Ability to challenge conclusions with objective evidence.
• Excellent GMP technical writing and documentation review.
• Experience working cross-functionally with Manufacturing/QA/QC/Engineering.

Responsibilities

• Review and approve GMP deviations/nonconformance investigations through closure.
• Evaluate investigations for technical accuracy, completeness, and regulatory risk.
• Challenge root-cause determinations and ensure supported conclusions.
• Guide investigation owners through milestones, requirements, and timelines.
• Review technical writing and identify weak or unsupported language.
• Evaluate CAPAs for appropriateness and effectiveness.
• Conduct or support interviews with Manufacturing, QA, QC, Maintenance, and Engineering.
• Coach investigators on root-cause analysis and best practices.
• Identify recurring issues and systemic quality concerns.
• Drive investigations toward timely closure in a fast-paced plant.

Skills

GMP experience

Root cause analysis

Quality writing

Investigation review

Cross-functional collaboration

CAPA evaluation

Deviations and nonconformances

Tools

COMET QMS

Job description

Insight Global is seeking a Senior Quality Investigation Specialist to support a GMP pharmaceutical site by reviewing, overseeing, and approving nonconformance and deviation investigations. The role focuses on drafting investigations as needed while ensuring high-quality reviews of root-cause analyses and CAPA effectiveness.

You will challenge root-cause conclusions, guide investigation owners, and drive timely, compliant closures in a 24/7 manufacturing environment.