QC Analyst - HPLC

Job description

Details:

Co-located alongside one of the company's major Research and Development (R&D) sites in Stevenage, Hertfordshire, the Global Manufacturing and Supply (GMS) Biopharmaceutical Central Testing Laboratory (BioCTL) provides release and stability testing services and other support to the company's global Biopharmaceutical supply chain.

As part of the site's continued growth we are now seeking to appoint a QC Analyst.

Reporting to the QC Team Leader, this job provides a unique opportunity to make your mark within a growing operation employing a wide range of technology, spanning traditional methods through to the very latest developments in support of late-phase clinical and commercially marketed biopharmaceutical 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.

To achieve this, the BioCTL team conduct biochemical analysis of products and provide specialist and technical scientific knowledge and expertise to evaluate all aspects of the laboratory functions.

Your Responsibilities would be :

- 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 work with the line manager or designated analyst to interpret tests results as required.
- To be familiar with chemical and biochemical methods, test specifications and sampling regimes, and the impact they may have on the product.
- 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 ensure compliance with established procedures and Departmental Safety Codes of Practice.
- To deliver and assess formal training programmes for staff and trainees as required.
Ensure that the department is kept in a safe, clean and orderly fashion and maintained in an inspection ready state.
- Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance.
- 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 requirements.
- Work in a safe manner and in compliance with Safety Codes of Practice and policies.
- To use Root Cause Analysis, and other OE tools.

If you're excited by the challenge of contributing to further growth and developing your career within a dynamic, fast paced environment, we'd very much like to hear from you.

Closing date for applications: Midnight on Wednesday 17th June 2016.

When applying for this role, please ensure your CV clearly demonstrates your relevant capabilities and use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined above. The information you provide in your CV/cover letter will be used to assess your application.

Thank you for your interest in this opportunity.

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:

• Biochemistry degree or relevant equivalent and three years analytical experience
• To understand the principles and have experience of Biopharm analytical techniques such as Capillary Gel Electrophoresis, cIEF, SDS-PAGE, HPLC, ELISA, Compendial Techniques.
• 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.

Preferred qualifications:

• Experienced on working to GMP
• 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.