GMP QC Environmental Monitoring Specialist

Infotree Global Solutions; Frederick (MD); Presencial; USD 52.000 - 78.000; Tempo integral

Resumo da vaga

Infotree Global Solutions seeks a detail-oriented QC Environmental Monitoring Executive to oversee routine environmental monitoring in a pharmaceutical manufacturing facility. You will ensure compliance with GMP standards, perform viable and non-viable monitoring, and maintain accurate records of EM data.

You will monitor environmental parameters, support trend analyses, and assist investigations into excursions while following SOPs and data integrity requirements.

Qualificações

• B.Sc./AA in Microbiology, Biotechnology, or related Life Sciences.
• Ideally 1 year of experience in QC Environmental Monitoring in the pharmaceutical industry.
• Basic knowledge of cleanroom monitoring practices, aseptic area behavior, and GMP guidelines.
• Good documentation and communication skills.
• Freshers with relevant academic knowledge may also be considered.

Responsabilidades

• Perform routine environmental monitoring of cleanrooms and controlled areas.
• Conduct viable monitoring (settle plates, active air sampling, and surface monitoring).
• Perform non-viable particle monitoring as per approved SOPs.
• Monitor and record temperature, relative humidity, and differential pressure.
• Ensure proper handling, incubation, and documentation of environmental monitoring samples.
• Maintain EM records, logbooks, and reports in compliance with GMP requirements.
• Assist in environmental monitoring trend analysis and investigation of excursions.
• Ensure adherence to SOPs, cGMP, and data integrity requirements.

Conhecimentos

Environmental monitoring

GMP compliance

Documentation

Communication

Formação

B.Sc./AA in Microbiology

Ferramentas

LIMS

Descrição da vaga

Infotree Global Solutions seeks a detail-oriented QC Environmental Monitoring Executive to oversee routine environmental monitoring in a pharmaceutical manufacturing facility. You will ensure compliance with GMP standards, perform viable and non-viable monitoring, and maintain accurate records of EM data.

You will monitor environmental parameters, support trend analyses, and assist investigations into excursions while following SOPs and data integrity requirements.