QC Shift Supervisor

LumiraDx is a medical technology company developing, manufacturing, and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA and is supported by a global sales network, LumiraDx currently has over 600 employees worldwide. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused, and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company. This role will initially work a shift of 06:30-15:00 1 week and 14:30-22:30 the next week. We plan to move to 24/7 shifts later in 2020 (exact shift pattern to be confirmed) You will be responsible for managing, supporting and developing a (shift-based) QC team in the routine testing and analysis of raw materials, development batches and final product. Key areas of responsibility Review of QC supporting area documentation (Batch records, logs etc) Planning, scheduling and support of QC testing activities in line with standard operating procedures and production schedules. Ensuring adequate resource is available for QC processes. Plan supply of material in the QC laboratory to ensure availability for QC process and ensure efficiently managed within area. Highlighting issues in a timely manner and resolving where possible. Ensure all routine maintenance and laboratory activities and records are completed to ensure compliance. Ownership of shift Quality Events. Monitoring instrument trends for reference equipment. Testing of test strip batches and final product using calibrators, spike and clinical blood samples. Preparation of spiking solutions, buffers and reference reagents. Assist in the transfer of assay calibration process from R&D Write and maintain standard operating procedures and work instructions for QC and support review and approval process. Ensure timely communication of all process observations/deviations and carry out investigation and resolution of these as required. Ensure full compliance with all relevant GMP and HSE requirements. About you: We are looking for an experienced and enthusiastic QC Shift Supervisor with: Background in a scientific role Experience of working in a QC environment Management Experience Knowledge of statistics and working with biohazards would be beneficial but not essential Apply for this Job