QA Operations Lead
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
QA Operations Lead - Site based at our sites in San Diego
Permanent / Full time
The QA Operations Lead is responsible for leading the inspection of printed materials, inspection/release of raw materials, releasing intermediate products, and the review / release of finished goods. The Quality Operations Lead ensures any nonconforming materials are identified and quarantined quickly and effectively. Collaborating with Quality Engineering to disposition nonconforming materials. The QA operations Lead works closely with operations and supply chain to identify material priorities an effectively communicates those priorities to the QA Operations team members. The QA Operations Lead will help develop department metrics, own relevant departmental SOPs and update as required.
- Supervise Quality Associates that perform receiving inspection, review device history records, and release finished products to the warehouse.
- Review Device History Records (DHRs) for molecular diagnostics and protein reagent and approve product release through the Enterprise Resource Planning system (ERP).
- Facilitate resolutions for discrepancies in DHR quality records; work with document preparers to resolve questions, inconsistencies or missing data issues.
- Perform incoming material inspections, review CofC/CofA including visual inspections when needed.
- Perform inspections of packaged product to ensure completion and accuracy.
- Provide data and/or metrics related to accuracy, completeness and cycle times for records being reviewed.
- Provides support through a general working knowledge of all LumiraDx quality programs.
- Participates in regulatory and internal audits, as needed.
- Interface with all functions and levels of management, as needed.
- Work on assigned special projects, as needed.
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem-solving and communication, along with the following experience:
- Bachelor’s degree (Life Sciences) preferred
- Previous Quality Assurance experience within a GMP regulated environment preferred.
- Prior exposure/experience in records management for a medical device/diagnostics or pharmaceutical company preferred.
- Computer literacy required; knowledge of Microsoft Office (including Word and Excel) required, experience with Enterprise Resource Planning (ERP) system preferred.
- Ability to pay close attention to detail is required.
- Strong planning, organizational and time management skills are required.
- Must be self-motivated with the ability to work with minimal supervision; must also be able to work as part of a team.
- Technical writing background/experience is a plus.
- Excellent written and verbal communication skills are essential.
For further information and to apply for this role, please click APPLY