QA Specialist - 21 CFR Part 11

A company is looking for MES Testing Staff for Ignition Track & Trace in a remote setting.

Key Responsibilities :

Design, develop, and execute comprehensive test cases for Ignition Track & Trace workflows

Validate Jython scripts and Ignition MES modules in accordance with 21 CFR Part 11 and GxP compliance standards

Identify, log, and track software defects using standard defect tracking tools

Required Qualifications :

Hands-on experience with Ignition MES and Track & Trace module testing

Strong understanding of 21 CFR Part 11, GxP, and other regulatory compliance requirements

Proficient in defect tracking, test documentation, and validation protocols

Experience in regulated industries such as pharmaceuticals, biotech, or food & beverage

ISTQB or equivalent QA certification is a plus