Lead Investigator: Quality & Root-Cause Expert

Aveva Drug Delivery Systems Inc; Florida; On-site; USD 85,000 - 110,000; Full time

Job summary

Aveva Drug Delivery Systems Inc in Florida is seeking a Lead Investigator to drive root-cause analyses and ensure timely investigations with effective corrective and preventive actions. You will coordinate across Production, Technical Services, Engineering, Supply Chain, Quality Control and Quality Assurance to close investigations per procedures.

The role requires an associate or bachelor’s degree in sciences, strong analytical and project-management skills, and knowledge of cGMP, FDA

Qualifications

• Analytical problem solving and troubleshooting.
• Experience in project management and coordination across functions.
• Familiarity with cGMP, FDA, and regulatory requirements.

Responsibilities

• Conducts investigations (product, process, deviations) and initiates corrective actions.
• Identify root causes and develop corrective and preventive actions.
• Lead cross-functional reviews with OPS, TS, SC, ENG, QA, RA.
• Prepare open investigations list and monitor progress with stakeholders.
• Project manage CAPA implementation and follow-up.
• Ensure compliance with company policies, safety rules and ethics.

Skills

Root cause analysis

Project management

cGMP knowledge

FDA compliance

SAP

Word & Excel

Education

Associate or Bachelor's degree in Sciences

Tools

RCCA tools

Job description

Aveva Drug Delivery Systems Inc in Florida is seeking a Lead Investigator to drive root-cause analyses and ensure timely investigations with effective corrective and preventive actions. You will coordinate across Production, Technical Services, Engineering, Supply Chain, Quality Control and Quality Assurance to close investigations per procedures.

The role requires an associate or bachelor’s degree in sciences, strong analytical and project-management skills, and knowledge of cGMP, FDA