Senior Quality Investigator - Root Cause & Projects (cGMP)

Aveva Drug Delivery Systems; Florida; On-site; USD 65,000 - 75,000; Full time

Job summary

Aveva Drug Delivery Systems in Miramar, FL seeks a Lead Investigator to ensure timely root cause analysis for investigations. The role analyzes reports, ensures procedures are followed, and coordinates cross-functional teams including Production, Technical Services, Engineering, and QA to implement corrective actions.

Qualifications include a science degree and 5-8 years in a cGMP environment, with strong project management, RCCA tools, and regulatory knowledge.

Qualifications

• Associate or Bachelor's degree in Sciences from an accredited college or university.
• Experience in project management and RCCA tools.
• Fluency in English written and verbal; strong organizational skills.

Responsibilities

• Conduct investigations for deviations (product, validation, stability, process) per procedures.
• Identify root causes and recommend corrective and preventative actions with cross-functional teams.
• Notify team leaders of failures and ensure investigations are initiated and completed.
• Review investigation reports for completeness and accuracy prior to approval.
• Lead impact analysis of corrective actions and present recommendations to managers.
• Maintain open investigations lists and track progress with stakeholders.
• Ensure compliance with company policies, safety rules, and regulatory requirements.
• Support audit readiness and alignment with cGMP, FDA, and DEA standards.

Skills

Project management

RCCA tools

Quality systems

cGMP/FDA knowledge

English communication

Education

Associate or Bachelor's degree in Sciences

Tools

Word

Excel

SAP

Job description

Aveva Drug Delivery Systems in Miramar, FL seeks a Lead Investigator to ensure timely root cause analysis for investigations. The role analyzes reports, ensures procedures are followed, and coordinates cross-functional teams including Production, Technical Services, Engineering, and QA to implement corrective actions.

Qualifications include a science degree and 5-8 years in a cGMP environment, with strong project management, RCCA tools, and regulatory knowledge.