Quality Assurance Specialist, Hoxworth Blood Center
Date: Jun 25, 2020
Location:Cincinnati, OH, US
Company: University of Cincinnati
Internal applicants must apply internally via SuccessFactors >
The Quality Assurance Department at Hoxworth Blood Center provides regulatory and quality oversight for all processes at the Blood Center.
The Quality Assurance Specialist will be responsible for conducting internal and external audits, providing quality assurance oversight for internal departments and CLIA regulated laboratories processes and procedures.
The Quality Assurance Specialist will assist with the development of new and revised department Standard Operating Procedures (SOPs), analyze data, report results, assist with process and equipment validations, and ensure compliance with applicable regulations.
The ideal candidate will:
Have experience with the following standards or regulations: 21 CFR Parts 210, 211, 600, 601, 606, 607, 610, 630, 640, 660, 42 CFR Part 493, ASHI standards, FACT standards, and AABB Standards.
Have worked in a clinical laboratory or FDA regulated environment.
Have auditing experience including as lead auditor
Consistently meet deadlines, be adaptable to changing priorities, and have excellent interpersonal and communication skills.
Have knowledge of histocompatibility testing
Have experience with quality management software.
Minimum Qualifications: Bachelor's degree with three (3) years experience;-OR-Associate's degree with five (5) years experience;-OR- seven (7) years experience. Degree and experience must be in a related field. Experience may require at least one (1) year supervision.
The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.
As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).
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