Team Lead Record Review

Versiti, Inc.•Dayton, OH

About The Position

Under the direction of the Manager of Record Review, the Record Review Team Lead is responsible for daily oversight and evaluation of department staff, workload, and activities to ensure regulatory compliance and completion of daily work within established turn-around time(s). The Record Review Team Lead serves as the subject matter expert (SME) and is responsible for independent decision making regarding critical steps in donor qualification, determining viability of product, and product release. The Record Review Team Lead is responsible for SOP improvements including review, revision, and collaboration; and assists in the implementation of SOPs, regulatory requirements, and blood center directives.

Requirements

Associate's Degree required
RN, LPN, Baccalaureate degree in Biological Science, or Medical Technology degree preferred
In lieu of academic degree, equivalent combination of education and/or commensurate experience (2+ years) in healthcare or blood banking required
4-6 years health care or blood banking experience required
1-3 years donor qualification or record review experience preferred
Demonstrate service excellence skills with ability to use tact and care in all situations according to people’s individual differences. required
Ability to apply judgment to detailed but very structured written or oral instructions. required
Able to organize work to provide productive work flow. required
Be able and available to work a flexible schedule as required based on volume, timing of blood collections and other departmental variables. required
Ability to write complex reports and correspondences. required
Ability to speak effectively with donors, volunteers and employees of the organization utilizing instructive or persuasive skills. required
Ability to work independently with minimum supervision, multi-task, and work with confidential information. required
Demonstrated knowledge of current Good Manufacturing Practices, Food and Drug Administration (FDA) regulations, and AABB standards related to blood center operations and collection requirements. required
Possess the following: • Professional demeanor • Projection of appropriate professional image • Analytical skills • High level of organizational and detail-oriented skills • Excellent communication and customer service skills. required

Nice To Haves

RN, LPN, Baccalaureate degree in Biological Science, or Medical Technology degree preferred
1-3 years donor qualification or record review experience preferred

Responsibilities

Responsible for scheduling and monitoring of staff in order to achieve goals related to performance metrics (turn-around time) and regulatory compliance.
Responsible for staff oversight, coaching, and mentoring to support operational needs.
Responsible for ensuring both technical and behavioral/interpersonal competencies are followed.
Responsible for creating and providing training and competency.
Serves as the subject matter expert (SME) and is 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.
Responsible for SOP improvements including review, revision, and collaboration.
Assists in the implementation of SOPs, regulatory requirements, and blood center directives.
Able to perform all duties of the Record Review/Lot Release department.
Identifies opportunities for process improvement.
Collaborate with other departments for investigation of deviations, tracking and trending of deviations, and initiating/implementing process improvement plans
Responsible for creating and supporting validation plans and protocols.
Serves as department leader and point-of-contact in the absence of the manager.
Other duties as assigned.
Performs other duties as assigned
Complies with all policies and standards