KEY DUTIES AND RESPONSIBILITIES

Provides key Donor Services support to the StimLabs Donor Services Team

• Participates in Donor Services daily activities.
• Acts as a quality representative within the organization, raising awareness for quality standards and education.
• Contributes to the development of donor services-related infrastructure for new processes.
• Assists on a variety of projects as designated by Donor Services Management.
• Conducts all activities and documentation related to Donor Eligibility.

Participates in daily operations of the Donor Services department including but not limited to:

• Communicates with tissue partners to obtain additional charting information as needed.
• Assists with development of Donor Services related Standard Operating Procedures, Work Instructions, and Forms; as requested.
• Performs the donor information sharing, rejection notices, and donor chart corrections process.
• Performs review of donor charts, infectious disease testing results, procurement culture results, and prepares the donor chart for final eligibility review to the StimLabs Medical Director.
• Assists with investigations and documentation related to Donor Services of CAPAs, Deviations, Nonconformance Reporting, and Complaints, as directed by Donor Services Management.
• Other Quality functions as designated and trained by Management (e.g., Tissue Utilization Records, Environmental Monitoring, Supplier File Maintenance, Quality Review of records etc.).
• General administrative tasks such as scheduling, filing, organizing etc.
• Support inspections and audits from regulatory agencies, as needed.

EDUCATION/CERTIFICATION

Bachelor's degree in a technical/relevant field, with at least one to three (1-3) years of donor chart review experience in a hospital, medical facility, medical device, biologic or tissue banking FDA regulated facility; or an appropriate combination of education, certification, and work experience.

REQUIRED KNOWLEDGE

Knowledge and understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations. Document Control Management (document changes as well as maintenance of Quality records) in a cGMP regulated environment required. Experience in tissue banking required.

Monday - Friday, 8am to 8pm, onsite, in office position. $35k - $45k depending on experience.