Quality Engineer Associate (Controlled Substance Investigator)

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13551331

The Quality Engineer Associate is responsible for the initiation and

completion of process deviations investigations aimed at identification

of root cause, and implementation of corrective actions to prevent

recurrence. This is a development role to expand the knowledge and

technical understanding of the investigator as it relates to risk

analysis, root cause assessment, and remediation activities.

**Key Responsibilities**

• Project management, time management, analytic and related leadership
  
  

skills.

• Work on the manufacturing floor and across the site for data
  
  

gathering from various sources.

• Performance of Root Cause Analysis (RCA) to determine the most
  
  

likely cause of the deviation.

• Work closely with the Quality Engineer to develop investigation
  
  

skills and expand knowledge of pharmaceutical manufacturing.

• Identification of Corrective and Preventative Actions to reduce
  
  

deviation recurrence.

• Align internal review team and area subject matter experts on an
  
  

agreed investigational path forward, author investigations and

support resolution through experimental DOE and execution.

• Ensures robustness (complete, accurate and defendable) of all
  
  

critical and major investigations.

• Ensures all CAPAs are implemented through cGMP systems (e.g. MBR
  
  

revision, training, etc.).

• Monitor and ensure effectiveness checks of CAPAs are conducted
  
  

Communication and Process Improvements.

• Provide timely updates to management on status of all GMP-related
  
  

investigations.

• Identifies opportunities for operational improvements for both
  
  

manufacturing, deviation and investigation management

non-conformance events.

• Ownership and implementation of actions related to CAPA, continuous
  
  

improvement, etc.

• Partner with aseptic operations, post production, and quality to aid
  
  

in investigations across all functions of the plant.