This position is responsible for administering aspects of the Quality Management System related to quality system compliance and continuous improvement. The ideal candidate will have a Quality Specialist/Engineering background in a medical device/in-vitro diagnostic, or molecular reagent company.
In this role, you will be independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of clinical and commercial drug substances and drug products in compliance with all applicable requirements.
The Quality Improvement Specialist, HAI will have knowledge and expertise in infection prevention practices. They will provide consultation, education, and technical program support informing infection preventionists at hospitals enrolled in the CalHIIN, which is part of The Centers for Medicare & Medicaid Services (CMS) Partnership for Patients (PfP) Initiative.
In this role, the selected candidate will able to communicate and work well on tasks with ancillary and ad hoc team members, community partners and stakeholders (including local health agencies) to plan, facilitate, and execute activities.
In this role, you will serve as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies.