We are currently recruiting for a Lab Analyst to join our BIOCMC department. This is an exciting opportunity for a graduate looking to start their career within a lab based role.
This role is full time based in our Covance Harrogate site.
- Conduct a scientific review of client methods/SOPs and make recommendations regarding the transfer and conduct of these assays into BioPharmCMC.
- Produce appropriate Analytical Procedures and associated Working Documents for the analytical methods.
- Check availability of reagents/consumables and order where necessary.
- Responsible for the generation of a Study File for an individual study including the generation of data tables where appropriate.
- Check availability of Test Article/Study Samples and review booking in procedure and information to ensure accuracy and appropriateness of received materials- notify QC SCi of arrival.
- Ensure Environmental Health & Safety Information are in place and available.
- In-Life Study Duties:
- During conduct of study, ensure that all assays performed are monitored for timely completion, and adherence to SOPs and Protocol requirements. Where this is not the case, ensure the deviation procedure is followed.
- Review data as it is produced for any potential OOS results and flag with QC SCi as soon as possible.
- The Study Supervisor may also be responsible for the transfer of data from CLE to the client and general client communication and updates; this should be performed under instruction from the relevant QC SCi.
- Keep the QC SCi informed as to the progress of laboratory work and issues arising.
- Review training records of individuals who form the study team to ensure adequate training is received and documented.
- Following Completion of Lab Phase:
- After completion of the analytical phase, review the study file to ensure all assays are completed and checked, tables are complete and checked and that the study file is acceptable. At this stage if changes/corrections are required, it is the responsibility of the Study Supervisor to organise in a timely and effective manner.
- Ensure completion of relevant eQA responses and notify QC SCi that comments have been addressed.
- General and Specific Analytical Skills and Techniques
- Good working knowledge of routine use and maintenance of equipment appropriate to BioPharmCMC, including trouble shooting.
- In depth working knowledge of data processing systems.
- Help support the efficient development of study methods within the relevant area.
- As required, provide appropriate training for BioPharmCMC staff to develop their skills and the group knowledge base. Should maintain a track of study activity and strive to keep projects on schedule.
- To help support equipment qualification within the BioPharmCMC Division. This may include qualification design and protocol preparation.