QA Supervisor
The Judge Group Inc.

Location: St. Louis, MO
Description: Our client is currently seeking a QA Supervisor

This job will have the following responsibilities:

• Primary Responsibilities
• Initiate, track, trend, lead, write, and close all investigations into internal failures and external customer complaints
• Drive completion of all corrective and preventive actions in a timely manner
• Assist department specific subject matter experts in root cause analysis
• Regularly conduct personnel interviews to learn sequence of events in root cause determination
• Review test data for chemical analyses as inherent part of investigations
• Develop investigation SOPs, work instructions, and conduct associated training
• Ensure proper verification of effectiveness for all corrective and preventive actions
• Maintain the corrective and preventive actions database and analyze trends
• Work with all aspects of operations (Production, Packaging, Project Engineering, Quality Assurance, Quality Control, Maintenance,...) to ensure timely completion of CAPAs
• Ability to escalate actions cross-functionally when deadlines are approaching
• Participate in daily quality meetings to speak on status of issues and bring awareness to / resolve any developing trends
• Immediately initiate and host meetings relating to failures
• Issue weekly reports on all open investigations and ensure timely completion of investigations
• Issue monthly reports on failure metrics and trends
• Handle and ensure completion of all raw material supplier nonconformance's

Qualifications & Requirements:

Education Requirements

•Bachelor of Science in Chemical Engineering or Chemistry Knowledge & Experience

Requirements

•Minimum of three years direct experience in conducting investigations, root cause analysis, and execution of CAPA in an FDA regulated environment

•Strong knowledge in root cause analysis and utilization of investigation tools and methods

•Strong critical thinking, analytical thinking, deductive reasoning, and problem-solving skills

•Strong knowledge of GMP and FDA expectations

•Strong technical writing skills and understanding of complex and complicated issues

•Ability to work in a fast-paced environment while meeting productivity demands

•Ability to present on issues, trends, and similar events with clear, concise, technical language

Contact: tduncan@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.