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 QC Microbiologist to join the team. The purpose of this role is to test and report on raw materials, intermediates, finished products, the manufacturing environment and stability samples to enable product release and meet regulatory requirements.
Your responsibilities in this role would be:
- Test and report on raw materials, intermediates, finished products and the manufacturing environment to enable product release to meet regulatory requirements.
- Participate in continuous improvement initiatives to enhance working practices.
- Support internal audits to maintain and improve Quality systems.
- Maintain stock control of QC test materials for use within the Microbiology Lab and Production areas.
- Co-ordinate microbiology OOS/OOT results to help identify contributory factors and assign root cause.
- Review and update departmental documentation.
- Support Senior Microbiologist and QC Manager with training of new staff.
- Liase and collaborate with other departments, provide guidance to ensure QC procedures are adopted and maintained.
- Assist in presenting GMP training to increase awareness of Microbiology.
- Provision of guidance and support to Manufacturing group to ensure sterility assurance such that products are fully tested and released to required microbiological compliance standards.
To be successful in this role, you will have the following skills and experience:
- HND/Degree level qualified in Microbiology or related subject
- Fully trained in all Standard Operating Procedures relating to QC testing.
- Thorough understanding of microbiological test methods and their application in OXB.
- Understanding of microbiological identification techniques and their use.
- Relevant experience in Microbiology laboratory techniques
- Basic knowledge of cGMP and cGLP
- Computer literate (Word, Excel), Good familiarity with Microsoft Office software
- Environmental monitoring of cleanroom facilities using settle plate, contact plate/swab, active air sampling and particulate monitoring.
- Bioburden testing of raw material, de-ionised water, and in-process product samples by membrane filtration.
- Endotoxin testing of in process samples.
- Microbiological identification using staining (e.g. Gram) and biochemical profiling (e.g. Biomerieux API).
- Fertility testing of microbiological media.
- Identifying OOS, atypical results and system failures and reporting these to line management.
- Contributing to drafting of departmental documentation – SOP’s, protocols, reports etc.
- Ensuring good documentation practices while recording results and maintaining records. · Carry out COSHH Assessments according to Company standards.
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.
Monday, Tuesday, Wednesday, Thursday, Friday
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.
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