Quality Investigation Lead: CAPA & Deviation Expert

Echo-Consulting-Group; Kentucky; Vor Ort; USD 85.000 - 125.000; Vollzeit

Zusammenfassung

ECHO Consulting Group in the United States is seeking a Quality Investigator to lead and execute CAPA investigations across GMP operations, ensuring timely, compliant closure. Bachelor's degree in Science or Engineering with 5+ years of related experience; bilingual English/Spanish preferred; strong root-cause methodologies; cross-functional collaboration; knowledge of QMS and regulatory requirements.

This on-site role offers opportunities to collaborate across manufacturing, QA/QC, and supply

Qualifikationen

• Bachelor's degree in Science, Engineering, or related field with 5+ years of directly related experience.
• Experience supporting deviations, nonconformances, CAPA, and investigations in regulated environments.

Aufgaben

• Lead and participate in root cause investigations for deviations and nonconformances in GMP operations.
• Track and monitor nonconformances and deviations with thorough documentation.
• Coordinate cross-functional teams to identify root causes and define CAPAs.
• Own CAPA identification, implementation, and effectiveness verification.
• Review approval of deviation, nonconformance, and CAPA records in QMS.
• Perform trend analysis to drive continuous improvement.
• Address observations from internal/external audits and supplier nonconformances.
• Ensure supplier-related nonconformances are documented and resolved with suppliers.
• Support change controls, risk assessments, and validation activities.
• Represent Quality on cross-functional teams and provide status updates.

Kenntnisse

Root cause investigation

Project management

Cross-functional collaboration

Documentation and record-keeping

Manufacturing QA/QC knowledge

Regulatory compliance awareness

Communication and presentation

Ausbildung

Bachelor's degree in Science/Engineering

Tools

QMS

Office software

Jobbeschreibung

ECHO Consulting Group in the United States is seeking a Quality Investigator to lead and execute CAPA investigations across GMP operations, ensuring timely, compliant closure. Bachelor's degree in Science or Engineering with 5+ years of related experience; bilingual English/Spanish preferred; strong root-cause methodologies; cross-functional collaboration; knowledge of QMS and regulatory requirements.

This on-site role offers opportunities to collaborate across manufacturing, QA/QC, and supply