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Senior Quality Assurance Specialist
hace 2 meses
Job Summary
We are seeking a highly skilled Senior Quality Specialist to join our team at IQVIA. As a Senior Quality Specialist, you will be responsible for establishing, reviewing, and amending global acceptance criteria for harmonized assay quality control material.
Key Responsibilities
- Perform global assay quality control reviews to monitor regional and/or global trends, and implement corrective actions when needed to establish or restore acceptable global performance.
- Monitor and review regional laboratory investigations performed for proficiency testing failures, analyzing global impact and trends.
- Manage global inventory stock levels of harmonized reagents, calibrators, and quality control material.
- Collaborate with vendors and assay manufacturers to maintain quality and harmonized assay performance.
- Facilitate global technical meetings and provide training to the Global Harmonization team and regional laboratory teams, as needed.
- Work closely with the assay development laboratory, regional production laboratories, scientific review, data management, vendors, and laboratory management to execute and fulfill duties.
Requirements
- Bachelor's degree in medical technology or equivalent required.
- 2-3 years' experience in a research laboratory/clinical laboratory environment or equivalent combination of education, training, and experience required.
- 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 and establish effective working relationships with coworkers, managers, and clients.