Quality Investigation Specialist – Deviations & CAPA

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 a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

Leading and executing investigations related to deviations, nonconformances, and Corrective and Preventive Actions (CAPA) under minimal supervision. This role ensures that quality events across manufacturing, laboratory, and supply chain operations are identified, investigated, and resolved in compliance with cGMP and applicable regulatory requirements.

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.

• Ensure supplier‑related nonconformances are documented, communicated, and resolved in close coordination with suppliers.

• Support change controls, risk assessments, and validation activities related to investigation findings.

• Represent Quality on cross‑functional teams, including incident triage and continuous‑improvement initiatives.

• Provide status updates and metrics on open investigations and CAPAs to Quality leadership.

• Ensure all activities are performed in accordance with cGMP, site procedures, and regulatory requirements.

Shift: Administrative - On‑site

Location: Multiple Locations, United States

Education:

Bachelor's degree in a Science, Engineering, or related field and 5+ years of directly related experience

Preferred Qualifications:

• Prior experience within the Pharmaceutical, Biotechnology, or Medical Device industries.

• 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).

• Must be fully bilingual (English/Spanish).

Skills:

• Strong root cause investigation and problem‑solving skills.

• Project management skills, with the ability to lead assignments through to completion.

• Ability to initiate and lead cross‑functional teams.

• Strong organizational skills and attention to detail.

• Strong knowledge of manufacturing, QA, QC, and validation processes.

• Strong written and verbal communication, facilitation, and presentation skills.

• Ability to work independently and interact effectively across all levels of the organization.

• Proficiency with quality management systems (QMS) and standard office/database applications.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.