Sterility Assurance Microbiologist

Sterility Assurance Microbiologist

Baxter International

Thetford, United Kingdom

Essential Duties and Responsibilities:

Operate as part of the Sterility Assurance group to perform:

• Quality System & Regulatory Compliance: Maintain alignment with EU GMP & Guidelines.
• Sample preparation and processing of biological indicators.
• Carry out environmental monitoring for classified areas.
• Support with atypical sterilisation investigations.
• Investigation and communication of “Out of specification” results and the identification and implementation of CAPA.
• Support for projects relating to environmental monitoring.
• Compliance with EHS/GMP/GDP/Company and corporate policies and external regulatory requirements.
• Other Activities as deemed to be required to support the Thetford manufacturing operation.

Qualifications

• Degree in Microbiology, Biomedical Science, Bioscience OR Pharmaceutical Science.
• Working in an environment where accuracy, numeracy, clear documentation and attention to detail are key requirements.
• Usual working hours will be Monday to Friday 37,5 hrs per week however flexibility in working hours to suit business needs is required. This will not be routine but may include early mornings, evenings and weekends periodically to support.