Quality Assurance Analyst
About The Position
The Quality Assurance Analyst serves as the department’s quality liaison for quality assurance activities, donor record review, regulatory reporting, patient safety, and quality improvement. The role reviews, processes, and maintains donor records and quality assurance documentation to ensure accuracy, completeness, and regulatory compliance. The analyst supports the organization’s Quality Management System through regulatory reporting, compliance monitoring, data management, and other quality assurance activities that promote regulatory readiness and patient safety. The position works with donor records and clinical information, resolves documentation discrepancies with appropriate parties, and distributes information according to partner contracts, organizational policies, and regulatory requirements. It also supports staff education and onboarding, audit readiness, accreditation activities, customer complaint and quality-event reporting, and cross-functional improvement initiatives. The role has no supervisory responsibilities.
Requirements
- Bachelor’s degree in health sciences or a combination of education and experience.
- Four years of work experience within a quality or related role.
- Fluency in written and verbal English.
- Ability to exercise initiative, critical thinking, and problem-solving.
- Proficiency with Microsoft Office programs, including Outlook and Teams, and other technology systems used in business operations.
- Strong organizational skills and ability to manage multiple and competing priorities.
- Attention to detail.
- Excellent verbal and written communication skills.
- Knowledge of quality assurance activities and quality improvement methodologies, including Corrective Action and Preventive Action (CAPA).
- Ability to demonstrate professionalism, determination, and compassion; maintain a motivated and positive attitude; support an inclusive work environment; collaborate as part of an interdisciplinary team; actively seek improvements; maintain a safe working environment and use Universal Precautions; and protect sensitive, protected, and confidential information.
Nice To Haves
- Prior experience in a healthcare organization, transplant center, or organ/tissue procurement organization.
Responsibilities
- Review, process, and maintain donor records for accuracy, completeness, timeliness, and compliance with regulations, standards, policies, and procedures.
- Compile, monitor, and review donor record documentation to support timely completion.
- Identify, investigate, monitor, and resolve donor record discrepancies in collaboration with appropriate parties.
- Maintain access to electronic hospital medical record (EMR) systems.
- Obtain, review, and interpret relevant clinical results and assess patient information to support donor record completion and patient safety inquiries.
- Distribute donor record information within timeframes specified by partner contracts, organizational policies, and regulatory requirements.
- Review and report positive serological, culture, and other post-procurement donor test results to appropriate personnel and agencies.
- Perform quality assurance activities that support regulatory compliance, patient safety, and continuous performance improvement through the Quality Management System.
- Complete regulatory reporting, data management, and quality assurance documentation within established timeframes.
- Provide staff education and guidance on quality assurance processes, regulatory requirements, organizational policies and procedures, and documentation expectations.
- Support onboarding and training of new QA Analyst staff.
- Assist with special projects and responsibilities assigned by management to identify improvement opportunities.
- Support internal and external audits by preparing documentation, responding to information requests, and supporting audit readiness and accreditation activities.
- Submit customer complaints, quality events, and non-conformances related to donor record documentation in the electronic Quality Management System.
- Participate in departmental meetings, committees, and cross-functional workgroups supporting quality, compliance, and continuous improvement.
- Prioritize and manage daily responsibilities to meet deadlines, quality metrics, and departmental goals.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
