QA CAPA Investigator: Root-Cause & Compliance Champion

Pinnaql, Inc.; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group is seeking a QA CAPA Investigation Specialist to support quality investigations within a regulated manufacturing environment. The role involves conducting and documenting CAPAs, nonconformances and related quality events, performing root cause analysis, and collaborating with cross-functional teams to ensure timely, well-documented resolutions.

Responsibilities include gathering data, preparing robust investigation reports, supporting corrective/preventive actions,

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Manufacturing or a related technical discipline
• Typically 35 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

Responsibilities

• 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

Skills

Root cause analysis

CAPA investigations

Technical writing

Cross-functional collaboration

Analytical skills

Organizational skills

Multi-task management

Verbal and written communication

Education

Bachelors degree in Engineering Science Quality Manufacturing or related technical discipline

Job description

Validation & Engineering Group is seeking a QA CAPA Investigation Specialist to support quality investigations within a regulated manufacturing environment. The role involves conducting and documenting CAPAs, nonconformances and related quality events, performing root cause analysis, and collaborating with cross-functional teams to ensure timely, well-documented resolutions.

Responsibilities include gathering data, preparing robust investigation reports, supporting corrective/preventive actions,