Specialist QA

Specialist QA with experience in regulated industry and 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 oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
  

Specific responsibilities include but are not limited to:

• Supports the 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 as assigned.
  
• Attends 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.
  
• 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.
  

• Doctorate or Master's Degree and 2 years of experience or
  Bachelor's Degree and 4 years of experience or 
  Associate Degree and 8 years of experience (Educational background: Microbiology, Biology of Life Sciences).
  
• Expertise in CAPA, Quality Assurance, NPI and Characterization Process. 
  
• Bilingual (English and Spanish)