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QC Microbiologist (12 month Maternity Cover)

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
26 Oct 2020
Closing date
23 Nov 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

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 (12 month Maternity Cover) 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 and a thorough understanding of microbiological test methods gained an a GMP or GLP environment
  • Understanding of microbiological identification techniques and their use.
  • Relevant experience in Microbiology laboratory techniques
  • 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.

Contracted Hours

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.

Collaborate. Contribute. Change lives

No agencies please

Company

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. 

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.comwww.oxbsolutions.com, and follow us on LinkedInTwitter and YouTube

Life at Oxford Biomedica

We value everyone’s unique contribution, we appreciate everyone’s individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It’s a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people’s futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business’ future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We’ll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning.  Our defined career pathways provide opportunities for everyone to achieve their career potential.  We make a difference, and so can you.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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