Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.
Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines. The team are accountable for internal and external audits, quality compliance and control.
We are currently recruiting for a Senior QC Microbiologist to join the team. The purpose of this role is to be responsible for the oversight and performance of environmental monitoring within the manufacturing facilities (operating at ISO 8 to ISO 5 classifications), and the collection, testing and data analysis of raw material and product microbiological testing to ensure that both the product and the cleanroom environments where they are made are in suitable biocontamination control.
Your responsibilities in this role would be:
Supervise and support a team of microbiologists.
Plan, organize and perform testing of raw materials, in-process, intermediates and final product Testing includes environmental monitoring, bio-burden (membrane filtration) and endotoxin testing (LAL), sterility testing (within isolator), microbial identification, growth promotion testing, operator qualification and media qualification testing using varying standard microbiological equipment following SOP’s in order to comply with regulatory requirements.
Maintenance of microbiological test data.
Ensure the microbiology laboratory is maintained to GMP standard and equipment is calibrated, maintained, cleaned and monitoried appropriately.
Write and review SOP’s/protocols/reports and other documentation to ensure compliance with required standards.
Ensure that quality documentation such as deviations, change controls and CAPA’s are raised and expedited to agreed timelines.
Review microbiology testing results to ensure data integrity.
Responsible for communicating and initiating any deviation or OOS micro results to manufacturing and other relevant departments in order to take corrective actions, and performing root cause analysis.
Communicating and scheduling with external engineers for equipment service and calibration without affecting business deadlines.
Represent the microbiology laboratory in communications with manufacturing and supply chain to synchronize microbial testing as and when required.
Support with aseptic fill finish processing microbiological testing activities.
To be successful in this role, you will have the following skills and experience:
Degree in Microbiology or other Life Science, or significant supplementing industry GMP QC Microbiology
Working within ISO 8 to ISO 5 clean rooms and experience within aseptic fill finish activities.
Excellent knowledge of cGMP requirements with specific reference to documentation and laboratory activities in order to ensure compliance is maintained.
Good understanding and knowledge of practical and theoretical microbiology techniques and aseptic techniques in order to enable effective and accurate environment monitoring and microbial testing.
Thorough understanding of GMP and cleanroom biocontamination control.
Relevant experience in microbiology laboratory and GMP/clean rooms.
Monitoring regulatory/industry updates.
Experience in bioburden testing, environmental monitoring, endotoxin testing, sterility testing, media qualifications, and growth promotion testing.
Ability to write technical reports and procedures.
Ensure excellent communication is maintained with other departments to achieve the business target.
Excellent oral and written communication skill.
To accommodate specific batch manufacture processes, the following shift pattern will be required: Monday – Friday 7:00 am – 3:00 pm Monday – Friday 2:00 pm – 10:00 pm. For some processes, you may be required to work some weekends and night shifts.
Notice of which shift you will be required to work for each batch of manufacture will be provided in advance to allow you sufficient time to plan your availability. A shift allowance is available.
For all other weeks of work (i.e. those which do not include these particular batch manufacture processes) your hours of employment will revert to core office hours: Monday – Friday 9:00 am – 5:00 pm with one hour for lunch, which is unpaid.
Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.