Senior Quality Specialist

Job Overview
Establish and monitor laboratory quality and technical systems including assay quality control, proficiency testing review, the scientific database and global laboratory 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.Performs work in accordance with ICH E6 Guideline for Good Clinical Practice.

Essential Functions
• Establish, review and amend global acceptance criteria for harmonized assay quality control material.
• Monitor and review regional laboratory investigations performed for proficiency testing failures.
• Update the Scientific Database with relevant assay technical data including the establishment and maintenance of the test code system
• Monitor and maintain global inventory stock levels of harmonized reagents, calibrators and quality control material.
• Provide training to Global Harmonization team and regional laboratory teams, as needed
• Minute and/or facilitate global technical meetings

Qualifications
• Bachelor's Degree in medical technology or equivalent Req
• 3 years experience in a research laboratory/clinical laboratory environment Req 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

Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers