QC Microbiologist

Job description

Working in the QC team in Oxford, you will be testing and reporting data surrounding raw materials, intermediates, finished products, the manufacturing environment and stability samples to enable product release.
*Client Details*
The client are a pioneering gene therapy business putting patient health at the forefront of their business through developing life-changing therapies.
*Description*
As a QC Microbiologist based in Oxford your responsibilities will be to:

* 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.
* Liaise 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

*Profile*
The client are open to a range of experience levels, with desirable characteristics being:

* Understanding of SOPs relating to QC testing.
* Hold a thorough understanding of microbiological test methods and their application including microbiological identification techniques and biochemical profiling
* Basic knowledge of cGMP and cGLP
* Computer literate (Word, Excel), Good familiarity with Microsoft Office software
* Experience with 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
* 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.
*Job Offer*
This is a hugely exciting time for the company as they are undergoing significant growth. They are offering a highly competitive wage with the opportunity for further training and development.