Senior Quality Specialist
hace 2 meses
**Essential Functions**
- Establish, review, and amend global acceptance criteria for harmonized assay quality control material.
- Perform global assay quality control reviews, monitor regional and/or global trends, implement corrective actions when needed to establish or restore acceptable global performance.
- Monitor and review regional laboratory investigations performed for proficiency testing failures looking at global impact and trends.
- Monitor and maintain global inventory stock levels of harmonized reagents, calibrators, and quality control material.
- Interact with Vendors/assay manufacturers regarding technical assay information required to maintain quality, harmonized assay performance.
- Minute and/or facilitate global technical meetings
- Collaborate with the assay development laboratory, regional production laboratories, scientific review, data management, vendors and laboratory management as necessary in the execution and fulfillment of duties.
- Provide training to Global Harmonization team and regional laboratory teams, as needed.
**Qualifications**
- Bachelor’s degree in medical technology or equivalent Req
- 2-3 years’ experience in a research laboratory/clinical laboratory environment Or Equivalent combination of education, training and experience Req
- Knowledge of clinical and/or research laboratory environment and safety and infection control procedures.
- Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures.
- Advanced Excel spreadsheet skills
- Ability to balance multiple priorities
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- English Fluent
**CV must be submit in English**
home-based
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