Information Systems Analyst 35453
Juncos - Puerto Rico
Job Summary
- The candidate should bring strong experience in deviation management within a GMP/GxP environment o
wnership of major and minor deviations and the ability to manage the full investigation lifecycle from initiation through closure.
Solid hands-on experience using Veeva QMS to generate designate document and close deviation records.
The candidate must be capable of leading investigations independently applying structured problem-solving methodologies and supporting CAPA development and effectiveness verification while maintaining inspection-ready documentation standards.
Since the resource will be managing records related to Computerized systems the candidate should possess basic to intermediate knowledge of computerized manufacturing systems including platforms such as MES SAP PCS or PI Historian to effectively assess and manage deviations related to technology and data integrity.
s degree and 6 years of directly related experience
OR High school diploma / GED and 8 years of directly related experience
8hrs shift 1st Administration / extended non-standard as needed for deviation closure
Required Skills:
The candidate should bring strong experience in deviation management within a GMP/GxP environment o wnership of major and minor deviations and the ability to manage the full investigation lifecycle from initiation through closure. Solid hands-on experience using Veeva QMS to generate designate document and close deviation records. The candidate must be capable of leading investigations independently applying structured problem-solving methodologies and supporting CAPA development and effectiveness verification while maintaining inspection-ready documentation standards. Since the resource will be managing records related to Computerized systems the candidate should possess basic to intermediate knowledge of computerized manufacturing systems including platforms such as MES SAP PCS or PI Historian to effectively assess and manage deviations related to technology and data integrity.
Required Education:
Masters degree OR Bachelors degree and 2 years of directly related experience OR Associate s degree and 6 years of directly related experience OR High school diploma / GED and 8 years of directly related experience 8hrs shift 1st Administration / extended non-standard as needed for deviation closure