QA Specialist 35383 Microbiology
Job Location:
Juncos - Puerto Rico
Monthly Salary:
Experience Required:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 ISOUSP
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
Required Skills:
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 ISOUSP 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.
Required Education:
Doctorate OR Masters 2 years of directly related experience Alternatively Bachelors 4 years of 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
