Founded in 1819, **MEMBERS ONLY**SIGN UP NOW*** embarks upon its third century - building on the past and defining the future by leading urban, public universities into a new era of innovation and impact through its strategic direction, Next Lives Here. Underscoring the power of creativity, ingenuity, invention and inclusion, what's Next will accelerate our unrivaled momentum, evidenced by eight straight years of record enrollment and rankings that include placement among America's top 100 public universities by U.S. News & World Report. Home to a diverse student body of nearly 47,000 and more than 4,200 distinguished faculty, the university combines its Research 1 (Very High Research Activity) Carnegie Classification with a physical setting that The New York Times recently acclaimed as "the most ambitious campus design program in the country.
JOB OVERVIEW The College of Medicine, Office of Medical Education is recruiting a Quality Assurance Specialist in Hoxworth Blood Center. This position will support the University's mission and commitment to excellence and diversity in our students, faculty, staff, and all our activities.
This Quality Assurance Specialist will be responsible for conducting and supporting compliance audits, supporting product release, and ensuring compliance with applicable regulations and standards. The Quality Assurance Specialist will support the Hoxworth Cell Therapy Division. This department provides novel therapeutic biologics to hospitals and pharmaceutical companies locally and nationally.
ESSENTIAL FUNCTIONS *Perform audits, create checklists, analyze data, report audit results and verify all changes are complete to ensure compliance with SOPs, accrediting agencies and state, local, and federal regulations. *Manage equipment calibration schedules and maintenance. *Assist with the development of staff training. *Assist in the planning, development and implementation of new programs. *Maintain, write and edit SOPs and train SOP writers and master list manager *Assist with the annual reports to senior management. *Act as liaison to internal departments and external entities. *Perform related duties based on departmental need. This job description can be changed at any time. REQUIRED EDUCATION *Bachelor's Degree *Seven (7) years of relevant work experience and/or other specialized training can be used in lieu of education requirement. REQUIRED EXPERIENCE Three (3) years of experience working in a clinical laboratory or FDA regulated environment.
ADDITIONAL QUALIFICATIONS CONSIDERED *A working knowledge of some or all of the following standards or regulations: GMP, GTP, ISO14644, AABB and FACT. *Previous experience reviewing batch production records, label approval and product release. *Have expertise performing and supporting compliance audits and self-inspections.
Ideal selection will be given to candidates who have prior Quality Assurance experience in a regulated environment (cell therapy, API, pharmaceutical, or biotech) and those who have cleanroom experience.
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT *Office environment/no specific unusual physical or environmental demands.
**MEMBERS ONLY**SIGN UP NOW***, 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).
**MEMBERS ONLY**SIGN UP NOW*** is an Affirmative Action / Equal Opportunity Employer / Minority / Female / Disability / Veteran.
