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Quality Control Specialist

HRS are currently looking for a Quality Control Specialist to join a leading Cell and Gene Therapy company based in the Hertfordshire area.

As the Quality Control Specialist you will be responsible for supporting the activities of the company's new GMP Quality Control Laboratories and ensuring that the new Manufacturing Centre meets the standards and expectations of its key stakeholders; regulatory authorities; and potential collaborators.



KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Quality Control Specialist will be varied however the key duties and responsibilities are as follows:

1.

You will assist in the technical transfer, validation and routine performing of analytical techniques used for the testing and release of cell and gene therapy products, including flow cytometry, qPCR and ELISA.



2.

As the Quality Control Specialist you will support the Sample Management function to ensure the QC group provides a timely, effective and efficient service for collection, transportation, storage and lifecycle management of microbiology and environmental monitoring samples requiring testing.

3.

Additionally, you will provide support for aseptic process qualifications such as aseptic gowning, good aseptic practises and media fills as well as supporting microbiological Out of Specification investigations.

4.

You will also generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods and reports.



ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Quality Control Specialist we are looking to identify the following on your profile and past history:

1.

Relevant degree in a Life Sciences related discipline plus industry experience.

2.

Proven industry experience working in a microbiology or aseptic biopharmaceutical manufacturing environment operating according to GMP.

3.

A working knowledge and practical experience in Flow Cytometry, Assay Validation and Development and qPCR.



Key Words: Quality Control , Specialist , GMP , cGMP , Laboratory , Biopharmaceutical , Cell Therapy , Gene Therapy , Microbiology , Aseptic , Flow Cytometry , PCR , Assay , Validation , Development , LIMS.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development.

We therefore welcome applications for any interested parties who fulfil the role requirements for this position.

HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists.

We look forward to helping you with your next career moves.