Senior QC Chemistry Analyst

at  Morgan McKinley

The successful candidate will be heavily involved in the running of the QC Chemistry laboratory including optimisation of the working processes for the laboratory as well as the maintenance and upkeep of laboratory instrumentation. They will play a leading role in the execution of QC laboratory tasks, working closely with colleagues in other local and corporate departments. They are required to work in a GMP environment meeting all expectations associated with the support of sterile manufacturing.

QUALIFICATIONS & EXPERIENCE

• Degree in Chemistry or equivalent
• Minimum of 2-5 years of experience in cGMP Quality Control Chemistry Laboratory environment.
• Experience in the use of HPLC, HIAC, Osmometer, pH etc. as well as classical wet chemistry analyses.
• Familiarity with OOS management, problem solving and root cause analysis required.
• Experience of method validation and method transfer.
• Strong understanding of the requirements of the Regulatory Standards
  Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

RESPONSIBILITIES:

• Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
• Prioritises safety and is diligent in the use of all appropriate safety tools, PPE and permits when sampling or when testing in the laboratory.
• Maintains a high standard of housekeeping within the Laboratory.
• Sampling and testing of raw material, in-process materials, finished and stability products.
• Works with a high level of analytical instrumentation, may be involved in the qualification of these instruments and in their routine maintenance.
• Should be capable of recognising atypical test behaviour and normally encountered equipment failure.
• Control and management of stability activities.
• Support quality aspects of materials management including supplier approval, supplier complaints and specification management.
• Actively participates and can lead laboratory investigations using structured problem solving processes.
• Develops lab procedures and supports site procedure development as required.
• Executes validation protocols for process validation and method validation. Participate in lab process validations, cleaning validations and equipment qualification.
• Reviews laboratory data and documentation as assigned.
• Daily up-keep and maintenance of Laboratory Equipment.
• Executes validation protocols for process validation and method validation. Participate in lab process validations, cleaning validations and equipment qualification.
• Is diligent in the completion and review of batch and testing documentation required to meet cGMP requirements.
• Accurate and timely recording of all GMP information is particularly important in a GMP laboratory.