San Diego, US
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
Quality Control (QC) Manager - based at Solana Beach, San Diego
Permanent / Full time
Quality Control Manager to join LumiraDx Fast Lab Solutions in San Diego, CA. This position supports the Molecular Manufacturing and Protein Manufacturing Teams via technical expertise and guidance, as they manufacture diagnostic reagents and materials that will be used within a variety of LumiraDx Products.
- Oversee Quality Control testing of all qPCR testing kits formulated at the San Diego Manufacturing site.
- Ensure proper documentation of all Quality Control testing at the San Diego Manufacturing site.
- Implement proactive maintenance of Quality Control instrumentation to minimize unscheduled downtime.
- Perform inventory control activities via the ERP system, including but not limited to material allocation and shelf-life queries for all materials utilized in the Quality Control Laboratory.
- Ensure daily and weekly laboratory cleaning procedures are performed by Quality Control personnel to prevent cross-contamination of reagent formulation laboratories.
- Investigate and recommend new technology for improving Quality Control Laboratory equipment maintenance, quality, and reliability.
- Write, review, and approve operation and maintenance procedures, as well as training manuals, as needed.
- This individual may generate and/or handle regulated (i.e., hazardous/non-hazardous) waste as part of this job. Ensure all waste generated is disposed of in accordance with federal/state regulations.
- Coordination of stability program and testing to establish and meet stability endpoints.
We are looking for a highly self-motivated individual with exceptional attention to detail and high level skills in leadership along with the following experience:
- MS or BS in biology, biochemistry, biotechnology, or related fields.
- Highly skilled in manual pipetting methods with extensive laboratory experience in an industry environment.
- Hands-on experience in molecular biology is preferred., specifically with PCR, RT-PCR and/or other amplification techniques.
- Familiarity with contamination controls in a molecular assay development environment.
- Experience with GMP (Good Manufacturing Processes) and applying them in the laboratory environment.
- Experience writing Standard Operating Procedures (SOPs) and Work Instructions
- Experience troubleshooting multiple instruments and assays
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