QC Bioassay Analyst
* Provide lab support for testing in Bioassay testing.
* The Job holder is responsible for the routine testing of In-process, Drug Substance, Drug Product, and stability samples for internally and externally manufactured Biopharm products. They are also responsible for ensuring that analytical tests are successfully transferred to the BioCTL, and method validation is performed where appropriate.
In this role you will:
* Maintain detailed laboratory records in accordance with current Good Manufacturing Practice (cGMP) through the use of controlled proforma or laboratory notebooks.
* Ensure that all records and test results are accurately prepared and checked, peer reviewed prior to submission for approval for authorisation and according to company, customer and regulatory requirements. Test samples utilising a range of biological or microbiological tests, in accordance with regulatory requirements and agreed schedules.
* Record deviations from the normal practice and out of specification/trend results appropriately and report them to the line manager; assist with investigations product and test anomalies.
* Facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory and responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures. Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance.
* Write, review and update SOPs and associated pro-forma used within the laboratory, prepare draft method of analysis and SOPs when new techniques are introduced in the area.
* Participate in the validation of test methods and equipment used in analysis to meet regulatory requirements.
Qualifications & Skills:
* Previous experience in analytical bioassay techniques is preferred.
* Has knowledge and understanding of analytical techniques and disciplines aligned to bioassays in the context of biopharmaceutical product release.
* Has an understanding of working to GMP and GLP compliance.
* Computer literate and competent in the use of corporate IT systems and Microsoft packages.
Preferred Qualifications & Skills:
* Has knowledge and understanding of biochemical techniques and analytical disciplines aligned to bioassays in the context of biopharmaceutical product release.
* Willing to be involved in working with a team as well as independently.
* Has a keen eye for detail.
* Is literate, numerate and computer literate.
* Has good planning and organising skills with ability for problem solving.
* Is able to communicate effectively with colleagues and managers within laboratory.
Closing Date for Applications - 04th April (EOB)
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