1 день назад
Analyst, Quality Control, Microbiology (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Analyst, Quality Control, Microbiology (Biotech): Performing environmental monitoring, water sampling, and GMP microbiological testing for mRNA manufacturing with an accent on sterility, bioburden, endotoxin, and method transfer activities. Focus on executing validated QC methods, investigating excursions and deviations, maintaining data integrity, and supporting audits and laboratory qualifications.
Location: Oxford, England; site-based and full-time on-site. Not eligible for remote work.
Company
develops an mRNA technology platform and medicines intended to change how treatments are created and delivered.
What you will do
- Perform routine environmental monitoring, critical utility sampling, and water analysis, including TOC, conductivity, bioburden, and endotoxin testing.
- Execute GMP QC microbiology methods for sterility, bioburden, endotoxin, release, stability, and method verification or validation samples.
- Support method transfers, equipment and method qualifications, validations, troubleshooting, and collaboration with internal and external testing laboratories.
- Maintain laboratory operational systems, prepare reagents, maintain equipment, manage samples, and complete data entry according to good documentation practices.
- Author and revise quality records, investigations, deviations, change controls, CAPAs, SOPs, protocols, and reports.
- Support internal and vendor audits, review data, train more junior staff, and follow GxP, data integrity, and company requirements.
Requirements
- BSc in a relevant scientific discipline and at least two years of Quality Control experience in a cGMP organization focused on microbiology.
- Hands-on experience with microbiology techniques such as Vitek, isolator technology, bioburden, BET, and sterility testing.
- Working experience in a GMP environment and the ability to follow SOPs, work instructions, and data integrity requirements.
- Ability to conduct investigations, prioritize multiple tasks, and collaborate effectively in a dynamic cross-functional matrix environment.
- Knowledge of current FDA, EU, and ICH guidelines and regulations is preferred.
- The role requires full-time presence at the site in Oxford and is not eligible for remote work. An enhanced pre-employment check may be required.
Culture & Benefits
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, mental health, and wider well-being support.
- Family-building benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
- Savings and investment programs, plus location-specific benefits.
- In-person collaboration supported by a 70/30 work model with an emphasis on teamwork, innovation, and mentorship.
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