QC Technician

Category: Manufacturing & Production

Employment Type: Direct Hire

Reference: BH-384187

The QC Technician will participate in the inspection and experiment planning, execution, and data analysis. This position is responsible for Quality Control of one or more products and will require hands-on routine analytical testing and working in a cGMP regulated environment. This position requires excellent documentation and results communication skills.

Duties and Responsibilities -

• Perform assay performance quality control for manufactured lots of disposable cartridges.
• Process release or rejection of materials and product in accordance with LightDeck procedures.
• Generate calibration for manufactured lots of disposable cartridges.
• Conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis of raw materials, in-process items, and finished products according to established operating procedures
• Experience working in a regulated environment (FDA, Quality Systems, ISO 13485:2016).
• Calibrates and maintains lab and analytical equipment.
• Generates and/or review's data for compliance to specifications and reports abnormalities.
• Good understanding of blook-based products, lab operations and protocols.
• Understanding of IVD medical devices and CLIA-waived devices.

• Bachelor's degree preferred
• A minimum of two years IVD / medical device industry experience and/or a minimum of one to two years in laboratory quality control, preferred.
• Experience working with laboratory-based biotechnology processes and principles required.
• Strong written and oral communication skills; must be able to deliver complex technical reports and communicate effectively with management, partners and technical audiences.
• Knowledge of statistical analysis.
• Deep understanding of how to manage and document sensitive and confidential situations and materials and Intellectual Property.
• Deep understanding of documentation, safety and other laboratory operations issues.