Versiti, Inc.
Location
Dayton, Ohio
The Specialist reviews records and reports associated with donor qualification and blood donation to ensure compliance with SOPs and regulatory guidelines before lot release. They are also responsible for verifying quality control maintenance and communicating unacceptable conditions to management.
A high school diploma is required, along with at least one year of experience in healthcare, laboratory, or blood banking. Knowledge of FDA regulations, AABB standards, and Good Manufacturing Practices is essential for this role.
Under the direction of the Manager of Record Review and/or the Record Review Team Lead, the Record Review Specialist is responsible for reviewing records and/or reports associated with donor qualification, blood donation, and lot release to ensure all processes are performed in accordance with standard operating procedures (SOPs) and are within regulatory guidelines. The Record Review Specialist verifies that associated quality control and maintenance are performed and within parameters for all processes. The Record Review Specialist ensures that review and lot release occurs within established turn-around times. Total Rewards Package BenefitsVersiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.
Reviews records and/or reports to ensure compliance with SOPs and within regulatory guidelines before lot release (release of blood components for labeling). Reviews daily, weekly, and monthly quality control and maintenance records of equipment, supply, and storage for the applicable collection date before lot release. Perform data entry of blood donation record into system if applicable. Initiates the appropriate deviation reporting forms and communicates with the appropriate management of unacceptable conditions for lot release. Organizes and correlates in an established manner all paperwork associated in the record review process for record retention purposes. Responsible for independent and/or collaborative decision making regarding critical steps in donor qualification, determining viability of product, and product release. Serves as the internal and external point-of-contact for complex questions/concerns related to Record Review/Lot Release. Contacts donors via phone, letter, or email to verify donation information. Participates in meetings and communicates effectively to foster a team environment. Assists in the development and achievement of departmental goals and objectives in support of the vision and mission of Versiti. Assists in the implementation of federal requirements, blood center directives, and SOPs. Seeks to participate in process improvement projects. Completes projects/tasks according to established project plans. Other duties as assigned. Performs other duties as assigned Complies with all policies and standards
Education High School Diploma required equivalent required In lieu of academic degree, equivalent combination of education and/or commensurate experience (2+ years) in healthcare or blood banking required Experience 1-3 years Minimum 1-year health care, laboratory, or blood banking experience required 1-3 years Minimum 1-year donor qualification or record review experience preferred
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