Overview
In this fixed-term onsite role at our Pirbright site, you support QC microbiology testing and environmental monitoring to enable vaccine batch release within a GMP environment. You work with a collaborative team, lead investigations and continuous improvement efforts, and maintain documentation and SOPs. As a subject matter expert, you contribute to compliance, equipment qualifications and site-wide QC activities. This position offers hands-on microbiology experience in a regulated setting.
Responsibilities
- Perform in-process and final product testing to support batch release
- Coordinate resources based on workload and priorities
- Lead investigations for deviations, OOS, CAPAs and change controls across functions
- Draft and update SOPs and material specifications
- Identify and drive continuous improvement projects to completion
- Ensure area compliance with HSE, Biosafety and GMP standards
- Act as QC SME for microbiology testing within QCR and manage a designated quality system
- Review environmental monitoring data and maintain EM database
- Support site utilities testing and broader Environmental Monitoring program
- Deputise for Microbiology Supervisor as needed
- Lead qualifications and upgrades for new or complex equipment
- Maintain lab equipment, reagents, consumables and controlled documentation
- Support sterilisation activities and waste management in restricted areas
Key requirements
- Bachelor’s degree in Life Sciences, Microbiology or equivalent
- Experience in a regulated Quality Control laboratory
- Knowledge of sterile manufacturing, environmental monitoring, water testing, sterility testing and microbiological identification
- Understanding of GMP/GxP and quality systems
- Strong attention to detail and accurate documentation
- Proficiency with Microsoft Office
- Well-organised with ability to meet deadlines and collaborate
- Comfort working in a restricted lab and following biosafety procedures
- Attention to detail
- Collaborative teamwork
- Proactive problem solving
- Environmental monitoring
- Sterility testing
- Microbiological identification
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