Donation Coordinator

The Donation Coordinator is responsible for the quality assurance of the acquisition of Birth Tissue through hospital donor sources.  Daily commuting requirements consist of travel to both hospital partners and StimLabs’ corporate office located in Roswell, Georgia.  Duties include, identifying and communicating with potential maternal donors and the accurate completion of donation paperwork which includes: an informed consent, risk assessment interview, Birth Tissue acquisition form, serology/culture requisition, Plasma Dilution form, and shipping documents.  Responsibilities also include educating hospital staff and physicians about StimLabs and the donation process.

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

• Participates in acquisition daily activities with weekend rotation for coverage.
• Suggests and implements improvements within the Beyond Birth (BB) program, Quality System and department.
• Acts as an acquisition representative within the organization, raising awareness for high standards and education.
• Contributes to the development of medical partners, hospitals, and Stimlabs employees.
• Assists or lead on a variety of projects as designated by Beyond Birth Management.
• Member of StimLabs Internal Audit Team.
• Conducts all activities and documentation related to Beyond Birth Quality Assurance and Quality Control.

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

• Provide education about donation, get informed consent to donate, and conduct risk assessment interviews.
• Coordinate with hospital and physician group staff to ensure completion of donor records
• Review donor records for donation eligibility.
• Prepare and submit serology requisition and ship vials to laboratory partner and coordinate courier pickup and drop-off.
• Package donated tissue in accordance with standards for delivery to StimLabs
• Ensure donor records are timely, accurate and within compliance with Stimlabs', FDA and AATB policies, procedures and guidance's.
• Deliver and receive tissue at StimLabs processing facility.
• Applying aseptic technique for donor storage
• Assist with training of new employees as well as hospital personnel.
• Acquire additional donor information or clarification as requested by Medical Director/Donor Services.
• Team and individual prioritization of duties and tasks as necessary to ensure assignments are completed in a timely manner.
• Review current procedures and identify opportunities for increased efficiency.
• Coordinate responses and resolutions to issues with appropriate internal and external parties.
• Maintain and promote positive and professional working relationships with associates and management.
• Perform related duties as assigned by management.
• Assists and collaborates on development of Standard Operating Procedures, Work Instructions, Forms, sampling plans, and specifications.
• Collaborates with Donor Services to complete investigations and documentation.
• Assists with investigations and documentation of CAPAs, Deviations, Nonconformance Reports, and Complaints, as directed by Beyond Birth Management.
• PB Pour activities: Perform PBS solution pour aseptically to consented tissue.

EDUCATION/CERTIFICATION

• Bachelor's degree in a technical/relevant field, with at least three to five (3-5) years of Quality Assurance and/or Quality Control experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience.

REQUIRED KNOWLEDGE AND QUALIFICATIONS

• Knowledge and understanding the tissue donation process (donor, regulatory requirements, eligibility, logistics, etc.)
• Experience interfacing with patients
• Experience working in hospital / healthcare setting
• Strong interpersonal skills
• 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
• Ability to assist team leads and managers in reporting, trending, and on-going training as required
• Experience with the tissue/ organ / blood donation process

Preferred Qualifications:

• Minimum 2 years related experience (tissue, blood donation/acquisition)
• Functional knowledge working within a cGMP regulated environment.
• Understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations.

StimLabs was founded in 2015 with a desire to advance the state of regenerative medicine. In pursuit of this goal, StimLabs has gathered exceptional scientific and clinical minds to develop and commercialize new bioactive technologies. While current technologies in medical devices, pharmaceuticals, and tissue banking provide useful products, StimLabs believes in the untapped synergy at the intersection of these independent domains. In the first steps towards this vision, StimLabs has launched a suite of next-generation amniotic-derived products. The success of these initial offerings has created a foundation on which StimLabs will continue building the future of regenerative medicine.