Quality Investigator

Location: College Station, TX
Department: Azzur Austin LLC

Job Description

We at Azzur Group are looking for an experienced Quality Investigator to join our Azzur Consulting: Austin team. 

The Quality Investigator is responsible for developing and performing the investigation, identifying the root cause(s) of the event, and documenting the results of the investigation. They may also assist in identifying the appropriate corrective of preventative actions to mitigate or eliminate the root causes, and in determining an Effectiveness Plan for the actions (including effectiveness criteria and timeframe).

Responsibilities
  • Develop the Investigation Plan and present the Investigation Plan to management or CAPA review board
  • Determine the Define/Measure/Analyze elements of the investigation
  • Determine scope of the investigation. Assume ownership and lead the Investigation phase of a CAPA
  • Identify appropriate/cross-functional team members and assemble the Investigation Team
  • Confirm corrections/containment identified based on the investigation results
  • Identify and employ appropriate investigation tools
  • Determine the appropriate data sources to be evaluated for the investigation, and obtain the required data
  • Investigate the root cause(s) of the issue
  • Clearly document the investigation results
  • Communicate the investigation results to affected departments
  • Ensure investigation follows the CAPA procedure, including all data entry requirements
  • Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
  • Collaborate with Action Owner/CAPA Owner to develop the Action Plan/Effectiveness Plan
  • Document Action Plan
  • Document Effectiveness Plan, including acceptance criteria and timeframe/number of opportunities

Qualifications
  • Bachelor's degree (in science or engineering preferred) or equivalent experience
  • Understand strategies and be able to invent new methods or new avenues of investigation
  • Strong analytical and problem solving skills
  • Technical writing skills
  • Good communication and leadership skills
  • Good interpersonal/communication/influencing/negotiation skills
  • Good project management skills
  • Experienced using DMAIC, fishbone, 5-why’s, FMEA, and other investigational tools.


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