Record Review & Lot Release Specialist

Versiti Blood Center of Ohio; Dayton (OH); On-site; USD 40,000 - 65,000; Full time

Job summary

Versiti Blood Center of Ohio is seeking a Record Review Specialist to ensure donor qualification, blood donation, and lot release records comply with SOPs and regulatory guidelines. You will verify quality control, maintain documentation, and ensure timely lot release.

Responsibilities include data entry, deviation reporting, and serving as a contact for complex questions related to Record Review and Lot Release.

Qualifications

• Review records to ensure SOP compliance and regulatory guidelines.
• Review quality control and maintenance records before lot release.
• Enter blood donation records into the system.
• Initiate deviation reporting and communicate with management.
• Organize and retain records for audit purposes.
• Independent/collaborative decision making on donor qualification and product release.
• Serve as internal/external contact for Record Review/Lot Release.

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.

Skills

Record review

Quality control

Regulatory knowledge

FDA regulations

AABB standards

Donor records

Education

High School Diploma

2+ years healthcare experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Office equipment

Job description

Versiti Blood Center of Ohio is seeking a Record Review Specialist to ensure donor qualification, blood donation, and lot release records comply with SOPs and regulatory guidelines. You will verify quality control, maintain documentation, and ensure timely lot release.

Responsibilities include data entry, deviation reporting, and serving as a contact for complex questions related to Record Review and Lot Release.