Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Description:
Perform one or more of the following duties and responsibilities in support of the client Quality Assurance program under minimal supervision.
Administrative Shift 8:00am - 5:00pm
Responsibilities:
- Supports the AML site GMP buildings Environmental Monitoring Process.
- Generates Environmental Monitoring and Critical Utilities trend reports.
- Participates and or Leads Risk Assessments to evaluate sampling sites for routine monitoring of GMP areas.
- Provides assessments to change control records, deviations, audit processes that need support from the Environmental Control perspective.
- Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network.
- Attends site GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation.
- Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
- Collaborates cross functionally to ensure the Quality Management System processes are performed in alignment with established procedures.
- Supports internal/external audits and inspections.
Competencies/Skills:
- Educational Background in Life Sciences (Biology, Microbiology)
- 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
- 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.
- Fully Bilingual in English and Spanish.
Education:
- Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.