Job Ref: 214836441

Date: 2021-10-06 17:03:10

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Our client, a leading Healthcare company who specialise in delivering innovation health solutions through their prescription medicines, vaccines, biologic therapies, and animal health products are looking for a QC Biologist/Analyst to join them on an initial 9 Month Contract basis in Milton Keynes (Inside IR35 – Umbrella Only).

The Role:

* To support analytical method validation / improvements and method transfers for Biology and Microbiology labs between sites.

* Support activities in the areas of qualification of critical reagents (biomaterials) used in Bio-assays, such as ELISA coats, ELISA conjugates, reference sera, toxins etc.

Duties:

* Expertise in Immunology techniques such as ELISA’s, hemagglutination tests, antigen mass assay is essential.

* Biology/Microbiology method validation / improvements and test transfer between labs/sites.

* Production and Validation and of biomaterials used in in-process and final product testing.

* Understanding of microbiology techniques is beneficial.

* Support in change management for introduction of new / improved methods and validation of new equipment.

* Be able to produce technical documents such as protocols, testing and execution plans and final reports.

* Update SOP’s and other GMP documents ensuring they are current and relevant.

* Ability to work on several projects simultaneously and be able to prioritise.

* Reporting and communication of results to stakeholders. Liaise with several departments – technical support groups, QA, Regulatory to drive project completion and deliver on milestones.

* The candidate will be required to report all laboratory activities in a clear, organised manner, in the form of reports, following the standard operating procedures.

Qualifications

* Good understanding and working knowledge of GMP Quality Systems

* Technical expertise in ELISA’s and other immunology techniques, including microbiology techniques.

* Minimum 3 years of experience with excellent understanding of testing within a laboratory environment

* Laboratory investigations

* Validation and method development

* Proficient in use of Microsoft Office especially Excel and Word.

* Good Protocol and Report writing skills.

* Ability to troubleshoot to resolve issues

* Degree in Biology/Microbiology

* Cross functional work experience

* Demonstrated scientific problem-solving capabilities

* Full UK driving licence

Desirable:

* Basic Statistical understanding Knowledge such as Minitab Statistical software

* Previous roles include interaction with other operations and technical roles

Please press apply now to submit your application. Alternatively, if you would like further information on this position or other positions win a similar sector, please feel free to contact Khush on (phone number removed) for a confidential conversation.

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