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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Do you like quality improvement and have an investigative spirit?
Are you interested in work/life balance?
If so, ARORA might have the position for you!
At Arkansas Regional Organ Recovery Agency (ARORA) we show kindness, are adaptable, we embrace forthright communication, and are dedicated in restoring lives. If you would like to be a part of a team that is passionate about making a difference in people’s lives then join our team; ARORA is currently searching for full time Quality Operations Specialist based in Little Rock, AR. This position will ensure compliance with CMS, FDA, AOPO, UNOS and OSHA standards and/or regulations and participate in Quality Audits of organ and tissue donor records. Duties include but are not limited to: scheduling, performing planned periodic audits, providing support with pre and post site surveys and assisting with quality metrics and process improvement programs.
Minimum Qualifications: Bachelor’s Degree in the following; Nursing, Health Information Management, Hospital Administration, Medical Technology, or Pharmaceuticals. Proficient in medical terminology.
Preferred Qualifications: 5 years of Quality Systems experience and advanced comprehension of Quality Systems.
The Arkansas Regional Organ Recovery Agency (ARORA) was established in 1987 as a non-profit, independent organ procurement agency. ARORA is headquartered in Little Rock, AR with a satellite office in northwest Arkansas located in Fayetteville, serving 64 counties in the state.
ARORA’s mission is to make every effort to provide organs and tissues for life-saving and life-enhancing transplantatio...n. This goal will be accomplished through continuous hospital involvement, which includes hospital training. ARORA also encourages community involvement by providing public education. The staff strives to be ethical and professional while coordinating donor recovery, and provides dignity, honor and respect to both donor families and recipients.