QA Investigator

  • Location: St. Louis, MO
  • Type: Contract To Hire
  • Job #37894

Quality Assurance Investigator
St. Louis, Missouri

Description: The QA Investigator will be responsible for conducting investigations, ensuring quality through root cause analysis and execution of CAPA, and will manage an excellent team of quality professionals. The successful candidate will have a background in Quality Assurance, with a concentration on Good Manufacturing Practices (GMP) and CAPA in an FDA regulated environment.

This is a full-time, Contract-to-Permanent-Hire Opportunity with a starting salary of $80-85K Based on Experience.

Job Duties and 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
  • Participate in cross functional meetings relating to failures
  • Assist with creating weekly reports on all open investigations and ensure timely completion of investigations
  • Assist with creating monthly reports on failure metrics and trends

Knowledge & Experience Requirements:

  • 3+ years working in a regulated pharmaceutical/chemical manufacturing environment
  • 1-3 years direct experience in conducting investigations, root cause analysis, and execution of CAPAs in an FDA regulated environment
  • Familiar with root cause analysis and utilization of investigation tools and methods
  • Strong critical thinking, analytical thinking, deductive reasoning, and problem-solving skills
  • Knowledge of GMP, ICH, pharmaceutical compendia 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
  • Proficient in various software programs (Word, Excel, eQMS…)

Candidates must be able to confidently pass a background check and drug screening for this opportunity.

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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