Jost Chemical Co.
  • 18-Aug-2020 to Until Filled (CST)
  • Quality Assurance
  • St. Louis, MO, USA
  • Full Time

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

 

Jost Chemical Co.
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