Specialist Record Review

Posted Yesterday
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Grand Rapids, MI, USA
In-Office
Junior
Healthtech • Social Impact • Biotech
The Role
Reviews donor, blood donation, quality control, maintenance, and lot release records for SOP and regulatory compliance. Performs data entry, investigates deviations, verifies product viability, communicates with donors and stakeholders, maintains retention records, and supports process improvements. The role requires accurate independent judgment, detailed documentation, confidentiality, strong communication, and knowledge of FDA, AABB, and current Good Manufacturing Practices requirements. This is a full-time, onsite Tuesday-Saturday position with rotating weekends and holidays.
Summary Generated by Built In
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 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.


Schedule 

  • Tues-Sat rotating weekends , some holidays 
  • 6:00 AM -2:30 PM in office 
  • Full time 
  • on site 
Total Rewards Package

CompensationThe target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications.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.

Responsibilities
  • 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
Qualifications

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

Knowledge, Skills and Abilities

  • 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

Tools and Technology

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

Skills Required

  • High school diploma or equivalent
  • Equivalent combination of education and/or commensurate experience may substitute for an academic degree
  • At least 1 year of healthcare, laboratory, or blood banking experience
  • At least 1 year of donor qualification or record review experience
  • Service excellence skills and ability to exercise tact and care
  • Ability to apply judgment to detailed, structured instructions
  • Ability to organize work and maintain productive workflow
  • Availability for a flexible schedule based on operational volume and timing
  • Ability to write complex reports and correspondence
  • Effective verbal communication with donors, volunteers, and employees
  • Ability to work independently with minimal supervision and handle confidential information
  • Knowledge of current Good Manufacturing Practices, FDA regulations, and AABB standards related to blood center operations
  • Professional demeanor and appropriate professional image
  • Analytical, organizational, detail-oriented, communication, and customer service skills
  • Experience using Microsoft Word, Excel, and PowerPoint
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The Company
1,265 Employees
Year Founded: 1947

What We Do

Versiti is a nonprofit blood health organization dedicated to improving patient health through discovery, diagnosis, and treatment. It collects, tests, and distributes blood products to hospitals across five Midwestern states; coordinates organ, tissue, and eye donation programs; provides specialized diagnostic laboratory and bleeding-disorder services; and conducts biomedical research into leukemia, hemophilia, sickle cell disease, gene and cell therapy, and personalized medicine.

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