QC Scientist

Hobson Prior have an amazing position to join a pharmaceutical organisation who are committed to providing life-changing therapies that can be developed for use in health services throughout the world. Our client is looking for a QC Scientist to join them on a permanent basis in Hitchin.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Partner with other QC personnel, QA, suppliers & service providers to assist in the development and maintenance of GMP approved QC Laboratory services.
• You will support in the review and reporting of statistical process trending charts for QC processes.
• Conduct laboratory analysis and result reporting to assure the QC service provision associated with the testing of starting materials, raw materials, excipients, in-process and final product sample testing is maintained in line with the requirements of each customer/external stakeholder.
• You will support other analytical groups, as required.
• You will conduct sampling of incoming materials, as required.
• Manage the site sampling plan for incoming materials.
• Actively participate with Operations team in the collection, transportation, storage and lifecycle
• management of samples requiring testing to be performed within the facility.
• Support the implementation and operation of a suitable electronic laboratory information management system (LIMS) for use in accordance with the requirements of GMP.
• Deliver interpretation and guidance to Programme Leadership Team and the Director of Quality, as required, of analytical test results, trends and any and all other areas of interest.
• Coordination of workload to ensure the availability of results to meet site manufacturing and release schedule.
• Provision of expert advice to clients and other external stakeholders, as required.
• Generate and review cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc.
• Contribute in material analysis related education and training and qualification.
• Support all anomalous result investigations , including OOS, OOT, and statistical variance issues.
• Support the QC function in operating to a high standard, and complies with cGMP and other appropriate regulatory standards.
• Support to ensure all QC laboratory equipment is maintained fit for purpose.
• Any other assigned duties.

Requirements:

• Educated in a Bachelor's degree in Chemistry, or a related discipline.
• Previous experience in an analytical testing laboratory.
• Proven experience of writing and reviewing GMP documents.
• Proven experience of looking critically at own and others work practices and procedures and identifying, reviewing, approving and implementing any needed improvements following site Change Management Processes.
• Demonstrated experience of motivating teams, whilst training and acting as a role model for staff associated with the GMP QC laboratories.
• Experience in interacting with clients and other client/external stakeholders.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.