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) monitoringSampling monitoring: equipment and techniquesData trending and evaluationMicrobiological testing methods and standards for clean rooms and controlled environmentsAseptic behavior in manufacturing areas to prevent contaminationFacility cleaning and disinfectionFamiliarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USPAbility to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring dataAbility to analyze trend reports and environmental/CU data to identify areas for improvementHands 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.