Scientist I - Analytical Teting in Deeside

Responsible for conducting and/or managing scientific research or quality testing performed in a laboratory environment including:

• Setting up, configuring, checking safety, installing, and maintaining laboratory equipment
• Planning, designing, conducting or following procedures within laboratory experiments to test the physical and/or chemical specifications of various substances, materials, and products to inform scientific research
• Estimating the resources and time required to conduct an experiment and monitoring performance to ensure these targets are met
• Collecting, preparing, and testing samples and recording observations
• Compiling research data and reporting results including with recommendations, applications, and conclusions
• Ensuring experiments and analyses are conducted within budgets and according to established scientific standards
• Researching, evaluating, and recommending investments in technology, equipment, systems, or other assets that will enhance the laboratory’s performance

To perform analytical testing on existing and new medical devices, skin care products and raw materials according to pre-determined protocols, SOPs, OCIs and TDs in support of product claims. To support business units in the method design, development, and validation of new analytical test methods upon request.

Key Responsibilities:

• Maintain compliance to ISO13485 and ISO9001 standards in accordance with GLP/GMP compliant procedures.
• Analysing, documenting, interpreting, and reporting laboratory data to GMP/GLP standards.
• Collation and reporting of laboratory data in technical reports.
• Assist with the drafting of new analytical methods for new products and/or techniques.
• Maintenance, calibration, documentation and updating quality records for the Analytical Laboratory.
• Support planned and ad-hoc analytical testing/test method development and support laboratory tasks as and when required.
• Perform laboratory/OOS investigations with some supervision incorporating problem-solving and troubleshooting for future improvements.
• Ensure the Analytical labs are maintained as a safe working environment, raising near misses where needed.
• Experience with a wide range of analytical equipment such as balances and pipettes through to HPLC and ICP-MS.
• Use of basic (e.g., Microsoft Word, Excel, SAP, etc.) and advanced (e.g., Waters Empower, ChemStation, Masshunter, Minitab etc.) software packages for ordering goods, data collection, analysis, statistical manipulation etc.
• Responsible for the ordering of laboratory consumables, chemicals, reagents and equipment when required.
• Act as support for other R&D groups with laboratory testing where required.
• Liaise with external vendors via telephone and when on-site including arranging of service contracts as well as the maintenance, servicing, and calibration of equipment.
• Actively execute improvement ideas (Lean/6S) for the Analytical Laboratory and other owned areas.
• Support improvements to current Analytical processes including updates to current test and operating procedures.

Skills & Experience:

• Preferably 1-2 years’ experience working in Medical Device/Pharmaceutical Industry within an R&D/product development role.
• Good working knowledge of laboratory Health and Safety Practices.
• Competent in basic and some advanced chemistry and laboratory techniques.
• Competent in following and adhering to SOPs, OCIs and TDs.
• A drive to understand the process of executing method validation for new products and raw materials.
• Basic experience in the utilisation of computerised systems to manage data and information.
• Good working knowledge of Microsoft Office - specifically Word and Excel.
• Understanding of compliance with FDA and European Regulations (ICH), Quality Systems and GMP Guidelines.
• Disciplined in adhering to group objectives including taking an active role in team collaborative activities.

Qualifications/Education:

• B.Sc., or equivalent in a scientific discipline – analytical chemistry desirable.

Working Conditions:

• Working in a laboratory environment with exposure to chemicals, reagents, and solvents.
• Competent in the disposal of chemicals, reagents, and solvents in accordance with site and environmental procedures.
• Ability to react and respond positively to changes in priority and workload including the ability to balance multiple, competing priorities to meet objectives.
• Use of VDU equipment.

Special Factors:

• Flexibility of task management and working laboratory environment is essential due to changes in business priorities and product launches.