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Specialist QA
Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
-Associates + 8 years of directly related experience OR
-High school/GED + 10 years of directly related experience.
Preferred: Microbiology, Biology or Life Sciences
Requisitos: Requirements: • Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring • Sampling monitoring:? equipment and techniques • Data trending and evaluation • Microbiological testing methods and standards for clean rooms and controlled environments • Aseptic behavior in manufacturing areas to prevent contamination • Facility cleaning and disinfection • Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP • Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel) • Ability to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring data • Ability to analyze trend reports and environmental/CU data to identify areas for improvement • Hands on experience in electronic systems for instance: Documentation platfo Requiere Mucha Experiencia Requires Expert Beneficios: Benefits Package: n/a
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