Quality Assurance - Principal Investigator

QA - Principal Investigator

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

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 nonconformances

Position Details

• Reports to QA Manager
• First shift, full time, position

Current Openings for Quality Assurance Principal Investigator Jobs at Jost Chemical Co.