Senior Microbiology Analyst - GMP QC Lead & Investigations

HAL Allergy Group; Leiden; Presencial; EUR 70 000 - 95 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

30 leave days

Pension plan

Health insurance

Resumo da oferta

HAL Allergy in Leiden seeks a Senior Microbiology Analyst to coordinate environmental monitoring and microbiological testing in a GMP environment. You will act as SME, drive investigations, and support product release.

You will lead the QC Microbiology team, trend data, review results, and assist with equipment qualification. A Bachelor's in Microbiology and 5+ years in pharma/biotech are required; Dutch and English fluency is essential.

Qualificações

• Bachelor's degree in Microbiology or related life sciences.
• Minimum 5 years in pharma/biotech.
• Experience with GMP environmental monitoring.
• Experience writing SOPs, deviations, CAPAs.

Responsabilidades

• Coordinate laboratory sampling and microbiological testing activities.
• Perform environmental monitoring of cleanrooms and water systems.
• Conduct microbiological analyses including sterility, bioburden, endotoxin, growth promotion testing, and microorganism identification.
• Review test results, reports, and laboratory documentation for accuracy and compliance.
• Lead troubleshooting efforts, investigations, deviations, change controls, and CAPAs.
• Training and mentoring QC Microbiology team members.
• Act as deputy for the QC Microbiology Supervisor when needed.

Conhecimentos

Environmental monitoring

Sterility testing

Bioburden testing

Endotoxin testing

Growth promotion testing

cGMP

Laboratory safety

Documentation

Formação académica

Bachelor's degree (HBO) in Microbiology

Descrição da oferta de emprego

HAL Allergy in Leiden seeks a Senior Microbiology Analyst to coordinate environmental monitoring and microbiological testing in a GMP environment. You will act as SME, drive investigations, and support product release.

You will lead the QC Microbiology team, trend data, review results, and assist with equipment qualification. A Bachelor's in Microbiology and 5+ years in pharma/biotech are required; Dutch and English fluency is essential.