The QC Analyst responsible for the routine testing of In-process, Drug Substance, Drug Product, and Stability samples for internally and externally manufactured Biopharm products. It is also responsible for ensuring that analytical tests are successfully transferred to the BioCTL, and method validation is performed where appropriate.
To independently perform analysis of samples submitted from both internal and external manufacturing sites for which the job holder has been trained.
- To test samples utilising a range of chemical, biochemical and biological tests, in accordance with regulatory requirements and agreed schedules. To apply a knowledge of Physico-chemistry testing to the provision of product testing and stability data. To be familiar with chemical and biochemical methods, test specifications and sampling regimes, and the impact they may have on the product.
- To work with the line manager or designated analyst to interpret tests results as required. Work in a safe manner and in compliance with Safety Codes of Practice and policies.
- To maintain detailed laboratory records in accordance with current Good Manufacturing Practice (cGMP) through the use of controlled pro forma or laboratory notebooks.
- To 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.
- Record deviations from the normal practice and out of specification results appropriately and report them to the line manager; assist with investigations product and test anomalies.
- To deliver and assess formal training programmes for staff and trainees as required.
- Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance. Ensure that the department is kept in a safe, clean and orderly fashion and maintained in an inspection ready state.
- To facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory.
- To be responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures. To record incoming samples according to the appropriate SOPs. To ensure all samples and materials are handled safely following departmental procedures.
- 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.
- To participate in the validation of test methods and equipment used in analysis to meet regulatory
- To use Root Cause Analysis and other OE tools.
Key Skills required:
- Has knowledge and understanding of the principles of data review and checking within a GMP environment.
- Has an understanding of working to GMP and GLP compliance.
- 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.
- Reliable and interested to learn and apply new techniques.
- Ideally B.S. in Biochemistry, Microbiology, Biology, or Chemistry
- Biochemistry degree or relevant equivalent and three years analytical experience
- To understand the principles of immunological assays.
- Has knowledge and understanding of biochemical techniques and analytical disciplines aligned to chemistry in the context of biopharmaceutical product release.
- Computer literate and competent in the use of corporate IT systems and software analysis packages
If you feel you would be suitable, please apply using your most up to date CV