What are the responsibilities and job description for the Quality - Lab Investigations position at Spark Life Solutions, Inc.?
Roles & Responsibilities :
- Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation.
- Conduct personnel interviews to determine root cause of the deviation.
- Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate.
- Set up and run meetings with cross-functional teams.
- Close deviations in a timely manner to meet business and compliance needs.
- Work with minimal supervision to drive deviations to closure.
- Work with Subject Matter Experts and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective and preventive actions, complete trending analysis, and recommend product disposition.
- Present and defend investigations during regulatory inspections, as required.
- Sustain a clean and safe work area using 6S principles
- Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).
Education & Experience :
