Analyst, Quality Control, Microbiology

• Conducting routine environmental monitoring (EM) and sampling of critical utilities such as water systems in a GMP manufacturing facility
• Executing microbiological analyses including TOC, Conductivity, Bioburden, Endotoxin, Sterility, and other GMP QC methods
• Supporting GMP testing for product release, stability, and validation samples
• Preparing, shipping, and receiving contract laboratory samples, including those for microbiological identification
• Participating in new microbiological method transfers in collaboration with Analytical Sciences & Technology (AS&T) teams
• Supporting development, implementation, and maintenance of laboratory systems in line with cGMP expectations
• Performing general laboratory support activities including reagent preparation, equipment maintenance, and housekeeping
• Participating in audit readiness activities, including support to internal and external audit teams
• Assisting in equipment and method qualifications, and potentially troubleshooting assay methods and instrumentation
• Drafting and revising SOPs, protocols, reports, and contributing to quality system documentation (e.g., deviations, CAPAs, EM excursions, and change controls)
• Applying Good Documentation Practices and ensuring full compliance with GxP and Data Integrity requirements
• Completing all assigned training per schedule and requalification timelines
• Supporting junior team members as required with data review, troubleshooting, and training

• BSc in a relevant scientific discipline with 5 years Quality Control experience in a cGMP organization with a focus on Microbiology
• Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others)
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred
• Working experience in a GMP environment
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment
• Ability to efficiently prioritise and complete multiple projects and tasks in a fast-paced environment
• Proven ability to conduct investigations

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred

• Best-in-class healthcare, plus voluntary benefit programs
• A holistic approach to well-being with access to fitness, mindfulness, and mental health support
• Family building benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras