Specialist QA 35382

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

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

• 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