Stability Analyst

Position Overview:

To perform physical and analytical stability testing on existing and new medical devices and skin care products according to pre-determined stability study protocols, SOPs, OCIs and TDs in support of product shelf-life and product labelling.

Key Responsibilities:

• Analysing, documenting, interpreting, and reporting laboratory data for stability studies to GMP/GLP standards.
• Perform maintenance, calibration, documentation and updating quality records for Stability equipment.
• Maintain compliance to ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.
• Provide technical knowledge to some stability studies with support from Senior Scientist.
• Experience with a wide range of analytical equipment such as balances and pipettes through to HPLC and ICP MS.
• Performs Lab/OOS investigations with some supervision incorporating problem-solving and troubleshooting for future improvements.
• Responsible for ordering of laboratory consumables, chemicals, reagents and equipment when required.
• Assist with the drafting of stability documentation such as protocols and reports.
• Ensure the Stability labs are maintained as a safe working environment, raising near misses where needed.
• Support planned and ad-hoc stability sample set-downs, pull requests and support laboratory tasks as and when required.
• Collation of stability data, including physical data retrieval, for stability/technical reports.
• Assist in the storage and retrieval of stability samples.
• Liaise with external vendors via telephone and when on site and arrange maintenance, service, and calibration contracts.
• Support the organisation of new and existing studies including sample retrieval.
• Support appropriate accelerated and real-time aging programmes that are suitable for the study in concept.
• Actively generate improvement ideas (Lean/6S) for the Stability laboratories and suite.
• Identify improvements to current stability processes.

Skills & Experience:

• Basic experience in the utilisation of computerised systems to manage data and information.
• Ability to react and respond positively to changes in priority and workload.
• Competent in following and adhering to pre-determined stability study protocols, SOPs, OCIs and TDs.
• An active team player disciplined in adhering to group objectives including taking an active role in team collaborative activities.
• Good working knowledge of Microsoft Office - specifically Word and Excel.
• Understanding of compliance with FDA and European Regulations (ICH), Quality Systems and GMP Guidelines.
• Proactive and positive mindset with an attitude that is open to change to embrace new ways of working and improvements.
• Competent in the disposal of chemicals, reagents and solvents in accordance to site and environmental procedures.

Qualifications/Education:

• B.Sc. or equivalent in a scientific discipline (e.g., Chemistry, Biology).

Working Conditions

• Working in a laboratory environment with exposure to chemicals, reagents, and solvents.
• Working with various storage chambers (freezer, fridge, incubators etc.) for sample retrieval and deposit.
• Good working knowledge of laboratory Health and Safety Practices.
• Use of VDU equipment.

Special Factors

• Flexibility of task management and working laboratory environment is essential due to continually changing priorities.