Analytical Chemist

Position Overview:

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.
• Method design, development, and validation 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.
• Write quality documentation such as Change Control Records, Non-Conformances, and Out of Specifications where appropriate.
• 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.
• Technical expert in specific laboratory equipment (e.g., HPLC) with experience with a wide range of analytical equipment such as balances and pipettes through to FTIR and ICP-MS.
• Writing SOPs, OCIs and TDs through to submitting into the Electronic Data Management System for approval.
• 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.
• Identify when laboratory consumables, chemicals and reagents are low and request for reorder whilst continuously improving stock management.
• Perform technical data checking for all analytical test methods.
• Perform technical approval checking for all reports generated by the Analytical function.
• 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.
• Train new and inexperienced members of staff in test method procedures and laboratory equipment where indicated within training records.
• Support and provide information for internal and external audits where required, in a timely manner.
• 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 3-4 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 advanced chemistry and laboratory techniques.
• Competent in following and adhering to SOPs, OCIs and TDs.
• Competent in the execution of 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.