Quality Control Specialist - Microbiology

An amazing opportunity has become available for Quality Control Specialist to join the Microbiology department at an exciting and fast growing Life Sciences business based in Hertfordshire.

As the Quality Control Specialist you will be providing expertise and support with Environmental Monitoring, microbiology raw material, in-process, final product and sterility testing.



Reporting to the Quality Control Lead, this role will help ensure that the new facility meets the standards and expectations of its key stakeholders, regulatory authorities, and potential collaborators.



KEY DUTIES AND RESPONSIBILITIES:

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

1.

You will support the set up and development of the new GMP Quality Control Laboratories and associated infrastructure.



2.

Support Microbiology test validations and method qualifications, along with providing support for aseptic process qualifications, such as aseptic gowning, good aseptic practises and media fills.

You will also support microbiological out of specification investigations.

3.

Ensure the QC function operates to a high standard and complies with cGMP and other appropriate regulatory standards.

4.

Ensure the QC group provides a timely, effective and efficient service for the collection (from manufacturing modules and other classified areas), transportation, storage and lifecycle management of collaborator and internally derived microbiology and environmental monitoring samples requiring testing.

ROLE REQUIREMENTS:

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

1.

Relevant degree in a Life Science discipline ideally microbiology or similar along with proven experience gained with a (bio)pharmaceutical GMP manufacturing business.



2.

Proven industry experience in GMP microbiology, and expertise in Environmental Monitoring, Sterility testing, in-process microbiological testing and final product testing.

3.

A working knowledge and practical experience with GMP documentation, ensuring the tracibility of all reagents, materials, equipment, standards and GMP sampling and testing.



Key Words: Microbiology | Environmental Monitoring | GMP | Sterility | Biopharmaceutical | Pharmaceutical | QC | Quality Control | Technical Expert |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant 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 scientists supporting science.

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




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