Validation Analyst

  • Contract

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

Validation Analyst to support temperature and humidity mapping activities within a GMP‑regulated pharmaceutical environment. This role is focused on data analysis, report generation.

 

Key Responsibilities 

*   Analyze temperature and humidity data from thermal mapping studies. 

*   Download data from data loggers and verify data integrity. 

*   Prepare technical **mapping reports**, including data analysis, graphs, and conclusions. 

*   Support execution and documentation of mapping activities for: 

    *   Refrigerators 

    *   Freezers 

    *   Incubators 

    *   Stability chambers 

    *   Controlled rooms / areas 

*   Support preparation and revision of validation and periodic re qualification protocols. 

*   Ensure compliance with **GMP, ICH, ISO**, and internal procedures. 

*   Maintain complete and traceable documentation in accordance with Good Documentation Practices (GDP). 

*   Support basic investigations related to temperature or humidity excursions. 

*   Collaborate with QA, Engineering, and Laboratory teams as needed. 

 

Qualifications

  • Bachelor’s degree in Sciences or Engineering 
  • 1-3 years of experience in: Thermal mapping data analysis, temperature and humidity data review, preparation of mapping reports 
  • Experience working in a GMP regulated environment
  • Microsoft Excel (data analysis and charting)
  • Bilingual (Spanish/English)

Additional Information

All your information will be kept confidential according to EEO guidelines.