- Bachelor of Science in in Biochemistry, Microbiology, Biology, or Chemistry
- GMP QC operations
- Understands 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
Masters in Biochemistry, Microbiology, Biology, or Chemistry
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
The Biopharm Central Testing Laboratory (BioCTL) is part of the Global Manufacturing & Supply organisation and is based on the Stevenage site. The BioCTL performs release and stability testing for a range of Biopharm clinical and commercial products including Tanzeum/Eperzan, Benlysta and Nucala. The BioCTL performs a range of physico-chemical and bioassay techniques and also provides technical expertise to the wider GSK organisation for these assay platforms. The BioCTL is a busy and dynamic department and is expanding to accommodate growth in the Biopharm portfolio in addition to continued support of existing products.
Quality Control (QC) is 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.
A fantastic opportunity has arisen for a QC Analyst with experience in one or more of the following areas: HPLC, Compendial methods e.g.(KF,UV).
The role purpose will include the following;
To independently perform analysis of samples submitted from both internal and external manufacturing sites for which the job holder has been trained.
Key responsibilities include;
- 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.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Closing date for applications: 18th August 2017
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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