Validation Analyst
QRC Group, Inc•Vega Baja, PR
15h
About The Position
Validation Analyst to support temperature and humidity mapping activities within a GMP‑regulated pharmaceutical environment. This role is focused on data analysis, report generation.
Requirements
- 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)
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
