Lead Quality Investigator: Deviations & CAPA (GMP)

ECHO Consulting Group; United States; On-site; USD 95,000 - 130,000; Full time

Job summary

ECHO Consulting Group is seeking an experienced CAPA Investigator to lead deviations and nonconformances under minimal supervision. You will ensure quality events across manufacturing, lab, and supply chain are identified, investigated, and resolved in compliance with cGMP.

Bachelor’s degree in Science or Engineering and 5+ years of related experience; bilingual in English and Spanish required. This on-site role spans multiple US locations with strong cross-functional collaboration and

Qualifications

• Bachelor’s degree in a Science, Engineering, or related field and 5+ years of directly related experience.
• Experience in GMP operations and CAPA investigations.
• bilingual English/Spanish required.

Responsibilities

• Lead and/or participate in root cause investigations for deviations and nonconformances in GMP operations.
• Track and monitor nonconformances and deviations site-wide with timely documentation.
• Coordinate cross-functional teams to identify root causes and define CAPAs.
• Own CAPA identification, implementation, and effectiveness-verification phases.
• Review and approve deviation, nonconformance, and CAPA records in QMS.
• Perform trend analysis on deviations and CAPAs to identify systemic issues.
• Address observations from internal and external audits and supplier nonconformances.
• Ensure supplier-related nonconformances are documented and resolved with suppliers.
• Support change controls, risk assessments, and validation activities related to investigations.
• Represent Quality on cross-functional teams for incident triage and improvement initiatives.
• Provide status updates and metrics on open investigations and CAPAs to Quality leadership.
• Ensure all activities comply with cGMP, site procedures, and regulatory requirements.

Skills

Root Cause Analysis

Project Management

Cross-Functional Leadership

Communication Skills

Documentation & Records

QMS Knowledge

Independent Worker

Quality Processes

Education

Bachelor's degree in Science/Engineering

Job description

ECHO Consulting Group is seeking an experienced CAPA Investigator to lead deviations and nonconformances under minimal supervision. You will ensure quality events across manufacturing, lab, and supply chain are identified, investigated, and resolved in compliance with cGMP.

Bachelor’s degree in Science or Engineering and 5+ years of related experience; bilingual in English and Spanish required. This on-site role spans multiple US locations with strong cross-functional collaboration and