QA Specialist -35382 - Microbiology

s (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 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 form the Environmental Control perspective.
• Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned.
• Attends AML 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.

directly related experience

Alternatively, Associates + 8 years of directly related experience

Alternatively, High school/GED + 10 years of directly related experience.

Preferred: Microbiology, Biology or Life Sciences