Specialist QA 35382
Jornada completa
Inteldot
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
- 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 platforms such as Veeva, Spotfire, LIMS, Maximo.
- Use of artificial intelligence tools such as data analytics and large language models
- Strong communication (both written and verbal), facilitation and presentation skills.
- 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
- Preferred: Microbiology, Biology or Life Sciences
Vacante publicada el Hace un mes
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