Validation Analyst
QRC Group, LLC•Vega Costera, PR
1d
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, and compliance support and is ideal for internal candidates with hands‑on experience in mapping analysis who are looking to grow within the Validation and Quality organizations.
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
