Job description Posted 29 June 2020

QC Specialist

There are 3 positions available 2 of which are in a HPLC/Compendial (KF, UV-vis, Appearance type testing) role and 1 which is more focussed on Electrophoresis.

Job Purpose

  • 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 and biochemical 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 electronic 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.
  • 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.
  • Update SOPs and associated pro-forma used within the laboratory
  • To use Root Cause Analysis and other OE tools to facilitate deviation and laboratory investigations

Additional information about the process

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