We are seeking a skilled Laboratory Analyst to join our team. This is a key role in the analytical laboratory project team, working on analytical project requirements through analytical laboratory transfer and commercialization in a new manufacturing facility.
The ideal candidate will have a B.Sc. in Analytical Chemistry, Microbiology or related discipline and a minimum of 2 years practical work experience in Medical Device/Pharmaceutical environment. Experience in technical transfers would be an advantage.
Key responsibilities include adhering to all company EHS guidelines and procedures with proactive involvement in laboratory safety initiatives, developing and validating laboratory test methods, collaborating on the preparation and execution of the Project Validation Master Plan, preparing validation and other related documentation, executing protocols and compiling reports generated from validation activities identified in the validation master plan, training on laboratory procedures, leading analytical method development/troubleshooting for the project laboratory groups, reviewing laboratory data ensuring accuracy for all relevant product within the project scope, validating laboratory equipment, software, spreadsheets and methods, performing validation, release, and non-routine testing as required, supporting site commercialization readiness, maintaining lab fitness for audits, ensuring compliance of the laboratory projects to all applicable quality, regulatory and Pharmacopeia requirements as well as all relevant divisional and corporate requirements, working within Filtration 2.0 laboratory calibration and preventative maintenance system, providing technical support to all F2.0 functional groups as required, ensuring laboratory project timelines are adhered to, and communicating with the laboratory supervisor, ensuring protocols, reports, test methods, SOPs and all other relevant documentation are drafted and approved prior to use, ensuring all laboratory investigations are completed in a timely manner and in accordance with site procedures, ensuring laboratory colleagues have full support for laboratory investigations and that standard root cause analysis tools are utilised, contributing to risk mitigation initiatives such as FEMAs and risk assessments, identifying and participating in Continuous Improvement initiatives, controlling, issuing and maintaining laboratory documentation, archiving laboratory data, logbooks and samples in accordance with procedures, ordering, receiving and controlling laboratory chemicals, reagents and consumables, and thoroughly investigating quality and safety issues using root cause analysis methodology and implementing robust corrective and preventative actions.