Beyond Birth Administrative Liaison

The Beyond Birth Administrative Liaison is responsible to support technical in office processes for the Birth Tissue acquisition program. Duties include review of critical records from Donation Coordinator’s field work with the birth mother and infant donor to ensure donation paperwork was accurately completed. This includes but isn’t limited to informed consent, Donor Risk Assessment Interview (DRAI), Birth Tissue acquisition form, serology/culture requisition, plasma dilution form, and applicable shipping documents. The Beyond Birth Specialist also supports inventory management for birth tissue donation kits, assisting with positive serology notifications, requesting, or retrieving medical records from OB/GYN offices, and various projects as assigned by management, and acts as back up personnel for the acquisition of donor tissue.

Provides key support to Beyond Birth program, Hospitals and the StimLabs organization

• Supports all daily acquisition activities.
• Suggests and implements improvements within the Beyond Birth (BB) program.
• Acts as an acquisition representative within the organization, raising awareness for high standards and education
• Complies with internal policies and procedures and external tissue AATB Standards and FDA Regulations
• Conducts activities and necessary documentation related to Beyond Birth Donation Coordinator’s and submitting donor records to Donor Services for the Quality review prior to Donor Eligibility.
• Fosters positive relationships with Partner Alliance, Donor Services, medical partners, hospitals, and StimLabs employees
• Assists or leads a variety of projects as designated by Beyond Birth Management

Essential daily operations of the Beyond Birth department includes but not limited to:

• Prepare and submit serology requisition and ship vials to laboratory partner, only as required based on business need
• Assists with, as directed by management, prioritization of tasks to ensure assignments are completed in a timely manner
• Acts as back up personnel for the acquisition of donor tissue
• Ensures the daily workflow of Beyond Birth donor charts is organized
• Pull donor charts that have completed the Donor Eligibility review process as indicated by Donor Services with Document Control for archive
• Performs initial donor chart and incoming tissue verification prior to transferring to Donor Services
• Requests medical records and follow-up information to support the Donation Coordinator’s via fax, email, or phone and retrieves urgent information from OB/GYN offices as needed or requested to facilitate donor chart reviews
• Maintain and promote positive and professional working relationships with associates and management
• Performs technical donor chart reviews to submit final charts to Donor Services
• Order and provide office supplies and assemble supplies to support the acquisition program
• Ensures acquisition supplies are prepared and stocked
• Ensure donor records are timely, accurate and within compliance with Stimlabs’, FDA and AATB policies, procedures, and guidance’s
• Assists and collaborates on development of Standard Operating Procedures, Work Instructions, and Forms, to improve program efficiency and growth
• Coordinate responses and resolutions to issues with appropriate internal and external parties
• Pull donor charts that have been rejected, file with Document Control for archive
• Perform related duties as assigned by management
• Accurately processing rejection notifications related to positive serologies, updating the spreadsheet, and advising the Director of Partner Alliance of such notifications
• Collaborates with Donor Services to complete investigations and documentation

EDUCATION/CERTIFICATION

• Understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations.
• Minimum 3 years related experience (human organ or tissue or birth tissue programs, or blood donation/acquisition)
• Associate degree in a technical/relevant field or an appropriate combination of education, certification, and work experience
• Quality Assurance and/or Quality Control experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility preferred
• Functional knowledge working within a cGMP regulated environment.

REQUIRED KNOWLEDGE AND QUALIFICATIONS

Knowledge and understanding the tissue donation process (donor, regulatory requirements, eligibility, logistics, etc.)

Strong organizational skills; attention to detail

Ability to communicate effectively both orally and in writing

Ability to multitask

Ability to work closely with internal and external colleagues

Ability to represent a positive and professional image with internal and external colleagues

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 preferred but not required.

Preferred Qualifications:

• Bachelor’s degree in a technical/relevant field or an appropriate combination of education, certification, and work experience.
• Certified Tissue Bank Specialist (CTBS) with the American Association of Tissue Banks