Quality Records Specialist- Donor Safety

Overview

Position Title: Quality Records Specialist – Guardian of Donor Safety

(Official Title: Specialist, Record Review)

Location: Onsite at Versiti Headquarters – Milwaukee, WI

About Versiti

Versiti is a fusion of donors, scientific curiosity, and precision medicine—all united by a single purpose: to recognize that the gifts of blood and life are precious. Home to the world-renowned Blood Research Institute, we power life-saving donations, fuel groundbreaking discoveries, and deliver cutting-edge diagnostic services. Our teams bring together experts in transfusion medicine, transplantation, stem cell and cellular therapies, oncology, and genomics—advancing patient outcomes and transforming care across our communities.

At Versiti, every role connects to our mission: to improve lives and empower healthcare partners to thrive.

About the Role

The Quality Records Specialist is the unseen hero ensuring every donation meets the highest standards of safety and accuracy. Think of this role as the final checkpoint before life-saving blood moves forward. You'll review donor records, audit documentation, spot errors, and confirm compliance with FDA, AABB, and GMP standards—all to protect the integrity of the blood supply.

This is detailed, meaningful work where precision matters—and every decision makes a difference.

What You'll Do

• Review and audit donor collection records daily for accuracy and compliance

• Investigate and document discrepancies, collaborating with quality and donor teams

• Analyze reports, verify SOP adherence, and ensure all data is complete and correct

• Use Excel, Teams, and email communication to stay connected and organized

• Support ongoing quality improvement and compliance projects

What You'll Bring

• High School Diploma (or equivalent) required; 2+ years of healthcare or lab experience preferred

• At least 1 year in healthcare, lab, or blood banking required

• Strong attention to detail, integrity, and accuracy

• Comfortable working with confidential data and regulatory documentation

• Proficiency in Microsoft Excel and Office Suite

• Knowledge of FDA, GMP, or AABB standards a plus

Why You'll Love It Here

Purpose-driven work—your accuracy helps save lives
Supportive, mission-centered team culture
Opportunities for growth in quality, auditing, or compliance
Focus-friendly environment

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.

Total Rewards Package

Benefits
Versiti 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.

Compensation: $20–$22/hour (based on experience)

Schedule: 1st Shift | 7:00 a.m.–3:30 p.m. | Rotating weekends & holidays | Flexible scheduling

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

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