Quality Assurance Engineer

Curium Live Forward

📍 Noblesville, Indiana, United States

Permanent Engineers

Job Description

Summary of Position

The Quality Assurance Engineer is responsible for supporting the Quality organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.

Work Schedule: 2nd shift Sat - Wed 3/4pm - 11:30pm/midnight. Schedule is subject to change.

Essential Functions

  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

  • Identify and implement Corrective Actions Investigate Exceptions (Deviations).

  • Generate or review Change Controls for Batch Records, Standard Operating Procedures, Standard Test Methods, Specifications, Data Sheets, etc.

  • Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects.