Compliance Analyst

Overview

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary

Under the supervision of department leadership, performs a second level review of records and data to ensure all processes are performed in accordance with standard operating procedures and all regulatory and accrediting standards. Assists in developing and maintaining documentation required for compliance, operations, training, quality, process improvement and/or environmental health and safety program. Partners with departmental management in collecting and analyzing data to support continuous improvement resulting in value-added customer/donor service and increased product yields and financial results while maintaining compliance and quality.

Responsibilities

• Uses data and information collected through medical record review to assess organ donor potential, to identify missed opportunities for donation, and to evaluate the effectiveness of referral processes, thereby supporting continuous improvement efforts and organizational growth.
• Maintains confidentiality while reviewing OPO/TB records to ensure compliance with organizational procedures and regulatory and accrediting standards.
• Interprets and prepares performance and compliance reports for donor hospitals, medical examiners, and tissue processors.
• Identifies and develops relationships with hospital partners' key health information management staff
• Ensures accurate and timely data collection, data entry, and data analysis related to medical record review, donor potential, and regulatory reporting requirements
• Prepares metric reports according to organizational standards for structure, style, format, order, clarity, etc., while using professional judgement within set parameters with regards to overall design and data presentation.
• Submits required regulatory reports to appropriate agency by required timeframe.
• Performs audits of operational functions.
• Practices a high degree of autonomy in a self-directed manner, demonstrating continuous improvement, innovation, and creativity in problem solving, sound critical analysis and judgment
• Generates the appropriate deviation reporting forms and communicates with departmental management.
• Supports external inspections and facilitate timely audit responses.
• Organizes and correlates in an established manner all paperwork associated in the review process for record retention purposes.
• Assists in the implementation of federal requirements, Versiti directives, and standard operating procedures.
• Works collaboratively with customers as needed to ensure timely submission of required donor information.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

***All new employees must obtain primary Covid-19 vaccination (single dose Johnson & Johnson or 2 dosages of Pfizer/Moderna/Novavax) prior to start date or have an approved accommodation prior to their start date. ***

 

Education

• Bachelor's Degree required
• Degree in a Biological Science preferred
• Equivalent combination of education and related experience (3-5 years) may be substituted for the degree with HR approval required

Experience

• 1-3 years experience in a regulated environment where change management and continual process improvement were required and successfully implemented required
• Experience in data analysis, record review, or quality control preferred

Knowledge, Skills and Abilities

• Excellent written and verbal communication skills.
• Knowledge of medical terminology.
• Demonstrated knowledge of current Good Manufacturing Processes.
• Strong analytical skills and attention to detail.
• Knowledge of and ability to apply quality management/process improvement tools including LEAN, root cause analysis, and use of statistics.
• Ability to analyze information and make recommendations for improvements and corrective actions.
• Ability to exercise initiative and independent judgement in addressing procedural, technical, and equipment problems.

Tools and Technology

• Personal Computer (desk top, lap top, tablet). required
• Multiple computer systems required
• General office equipment (computer, printer, fax, copy machine). required
• Microsoft Suite (Word, Excel, PowerPoint, Outlook). required

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Employment Type: FULL_TIME