12th February, 2025
Summary
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Specific responsibilities include but are not limited to:
• Supports the 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 form the Environmental Control perspective.
• Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned.
• Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
• Supports Continuous Improvement initiatives, programs, and projects.
• Collaborates cross functionally as needed to ensure the Quality Management System processes are performed in alignment with established procedures.
• Alerts senior management of quality, compliance, supply, and safety risks.
• Supports internal/external audits and inspections as needed.
Preferred Qualifications
• 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
• 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
Requirement
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree in Life Sciences (Biology, Microbiology) 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
- 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 oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
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