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.

Requirements

• 
  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)