QC Analyst (Bioassay)

Job description

Details:
GSK is a science-led, global healthcare company that produces innovative medicines, vaccines and consumer healthcare products.

We are committed to overcoming some of the biggest challenges in global health; delivering products of value in a responsible, sustainable way; and providing access to medicine for the world's poorest communities

Job Purpose:
The Quality Control (QC) Biopharm is responsible for ensuring that analytical tests are successfully transferred to the Central Testing Laboratory (CTL) and validated. Subsequently, these methods are employed to test drug substance, drug, product, and stability testing for internally and externally manufactured Biopharm products.

Both clinical material testing and commercial product testing falls under the remit of the Central Testing Laboratory. The laboratory will be responsible for testing all internal and external GSK biopharmaceutical products.

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

Key Responsibilities:
To independently perform Bioassay analysis of samples submitted from both internal and external manufacturing sites for which the job holder has been trained;

• Routine cell culturing and cell based Bioassay/Immunoassay testing in accordance with regulatory requirements and agreed schedules.
• To work with the line manager or designated analyst to interpret tests results as required.
• Provide information on 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 Company 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 company, site and departmental Safety Codes of Practice and policies.

Complexity:
• Position holder is governed by the requirements stipulated in Regulatory Licenses, GMP guidelines (FDA, MRHA) GSK policies and guidelines and SOPs.
• Assist with validation protocols, which includes devising test methods, and to compile validation reports.
• Investigate adverse results and to provide expert advice and recommendations to Production and Development, eg perform investigations for product and test anomalies.

Educational Background
Scientific/Technical
• BSc in Biology or equivalent, Cell Biology, Virology, Biochemistry or related scientific discipline
• Has knowledge and understanding of Bioassay/Immuno assay techniques and analytical 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.

Further Skills
• Willing to be involved in working with a team as well as independently.
• Keen eye for detail.
• Literate, numerate and computer literate.
• Good planning and organising skills with ability for problem solving.
• Able to communicate effectively with colleagues and managers within laboratory.
• Reliable and interested to learn and apply new techniques.

Application Details
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.

Thank you for your interest in this opportunity.

Closing date for applications: 1st December 2017

*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:
See below

Preferred qualifications:
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