Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift
Job Description:
Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.
Requirements & Qualifications:
Knowledge in:
- Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring
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Sampling monitoring: equipment and techniques
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Data trending and evaluation
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Microbiological testing methods and standards for clean rooms and controlled environments
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Aseptic behavior in manufacturing areas to prevent contamination
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Facility cleaning and disinfection
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Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP
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Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel)
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Ability to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring data
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Ability to analyze trend reports and environmental/CU data to identify areas for improvement
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Hands on experience in electronic systems for instance: Documentation platforms such as Veeva, Spotfire, LIMS, Maximo.
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Use of artificial intelligence tools such as data analytics and large language models
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Strong communication (both written and verbal), facilitation and presentation skills.
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Fully Bilingual in English and Spanish
Education
- 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
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Preferred: Microbiology, Biology or Life Sciences
