Deviations & CAPA Investigator—Quality Assurance

ECHO Consulting Group; Kentucky; On-site; USD 85,000 - 120,000; Full time

Job summary

ECHO Consulting Group is seeking a Quality Investigator to lead deviations, nonconformances, and CAPA efforts across manufacturing, lab, and supply chain operations. You will investigate root causes under cGMP, coordinate cross-functional teams, and ensure timely closure of CAPA actions and regulatory-aligned documentation.

The role requires a Bachelor’s in a science/engineering field with 5+ years in a regulated quality environment, and full bilingual capability in English and Spanish.

Qualifications

• Bachelor's degree in a Science, Engineering, or related field and 5+ years of directly related experience.
• Must be fully bilingual (English/Spanish).
• Experience in a Quality organization supporting deviations, nonconformances, CAPA, and investigations in a highly regulated environment.
• Working knowledge of root cause analysis methodologies (e.g., 5 Whys, Fishbone/Ishikawa, FMEA).

Responsibilities

• Lead and/or participate in root cause investigations for deviations and nonconformances identified in GMP operations (Manufacturing, Engineering, Supply Chain, QC, etc.).
• Track and monitor nonconformances and deviations initiated across the site, ensuring timely and complete documentation.
• Coordinate cross-functional teams to identify root causes and define effective, risk-based CAPAs.
• Own the CAPA identification, implementation, and effectiveness-verification phases for assigned investigations.
• Review and approve deviation, nonconformance, and CAPA records within the Quality Management System.
• Perform trend analysis on deviations and CAPAs to identify systemic issues and drive continuous improvement.
• Address observations identified during internal audits, external audits, and supplier nonconformances.

Skills

Root cause analysis

Project management

Cross-functional teamwork

Communication

QMS knowledge

Education

Bachelor's degree in Science/Engineering

Job description

ECHO Consulting Group is seeking a Quality Investigator to lead deviations, nonconformances, and CAPA efforts across manufacturing, lab, and supply chain operations. You will investigate root causes under cGMP, coordinate cross-functional teams, and ensure timely closure of CAPA actions and regulatory-aligned documentation.

The role requires a Bachelor’s in a science/engineering field with 5+ years in a regulated quality environment, and full bilingual capability in English and Spanish.