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
Skills Required
- Knowledge of environmental monitoring, microbial identification (Micro ID), and critical utilities monitoring
- Sampling monitoring techniques and equipment
- Data trending, evaluation, and statistical analysis of environmental/CU data
- Microbiological testing methods and standards for clean rooms and controlled environments
- Aseptic behavior in manufacturing areas to prevent contamination
- Facility cleaning and disinfection procedures
- Familiarity with regulatory requirements and quality standards: Annex 1, FDA Guidance, ISO-14644-1, USP
- Proficiency with Smartsheets and Microsoft Office (Word, PowerPoint, Excel)
- Ability to use software tools and statistical techniques to visualize, interpret, and report monitoring data
- Hands-on experience with electronic documentation systems (Veeva, Spotfire, LIMS, Maximo)
- Experience using data analytics and large language model tools
- Strong written and verbal communication, facilitation, and presentation skills
- Fully bilingual in English and Spanish
- Education: Doctorate OR Masters +2 years OR Bachelors +4 years OR Associates +8 years OR High school/GED +10 years
- Preferred: Degree in Microbiology, Biology, or Life Sciences
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
