QA CAPA Investigator: Root-Cause & Action Lead

Pinnaql, Inc.; El Paso (TX); In loco; USD 75.000 - 110.000; Tempo pieno

Descrizione del lavoro

Validation & Engineering Group, Inc. seeks a QA CAPA Investigation Specialist to conduct and document quality investigations, CAPAs, and related events in a regulated manufacturing environment.

You will analyze data, perform root-cause analyses, document actions, and support corrective actions with cross-functional teams. The role emphasizes thorough reports, timely tracking, and effectiveness checks to ensure actions resolve issues.

Competenze

• Bachelor’s degree in Engineering, Science, Quality, Manufacturing, or a related technical discipline.
• Typically 3–5 years of experience in Quality Assurance, Quality Compliance, Investigations, CAPA, or a related function within an FDA-regulated industry.
• Hands‑on experience conducting or supporting CAPAs, deviations, nonconformances, or quality investigations.
• Working knowledge of structured root cause analysis and problem‑solving methodologies.
• Strong technical writing and documentation skills.
• Strong analytical and organizational skills.
• Ability to manage multiple investigations and priorities simultaneously.
• Effective written and verbal communication skills.
• Ability to work collaboratively with cross‑functional teams.

Mansioni

• Conduct and document quality investigations, CAPAs, nonconformances, and related quality events.
• Gather and analyze relevant data, records, and supporting documentation.
• Perform structured root cause analysis using 5 Whys, Fishbone/Ishikawa, and other problem-solving methodologies.
• Identify root causes, contributing factors, and potential systemic issues.
• Prepare clear, accurate, and technically sound investigation reports.
• Support the development and implementation of corrective and preventive actions.
• Track assigned CAPA and investigation activities through completion.
• Support effectiveness checks to verify that implemented actions achieved the intended results.
• Collaborate with cross-functional stakeholders to obtain information, resolve open items, and complete investigations within established timelines.
• Review supporting documentation to ensure conclusions are based on objective evidence and appropriate technical rationale.
• Assist with trend analysis and identification of recurring quality issues.
• Support audit and regulatory inspection readiness activities as needed.
• Maintain complete and timely documentation in accordance with applicable procedures and regulatory requirements.

Conoscenze

Quality Assurance

Investigations

Root cause analysis

Technical writing

Communication

Formazione

Bachelor's degree in Engineering/Science/Quality/Manufacturing

Strumenti

FMEA

Electronic Quality Management Systems

Descrizione del lavoro

Validation & Engineering Group, Inc. seeks a QA CAPA Investigation Specialist to conduct and document quality investigations, CAPAs, and related events in a regulated manufacturing environment.

You will analyze data, perform root-cause analyses, document actions, and support corrective actions with cross-functional teams. The role emphasizes thorough reports, timely tracking, and effectiveness checks to ensure actions resolve issues.