QC Team Leader
Alloa or Glasgow, UK
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 is a high growth organisation. 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.
Role & Responsibilities
You will be working 24/7 shifts in a 365 day Manufacturing Operation. This role could be based at our site in Stirling OR North Lanarkshire and travel between both sites may be required.
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.
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.
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
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
For further information and to apply for this role, please click APPLY