Senior Donor Services Specialist
Posted on: June 12, 2021
KEY DUTIES AND RESPONSIBILITIES
key Donor Services support to the StimLabs
in Donor Services daily activities.
and implements improvements within the Donor Services System and
- Acts as a
quality representative within the organization, raising awareness
for quality standards and education.
to the development of donor services-related infrastructure for new
- Assist or
lead on a variety of projects as designated by Donor Services
- Member of
StimLabs Internal Audit Team.
all activities and documentation related to Donor
in daily operations of the Donor Services department including but
not limited to:
- Leads the
review of donor eligibility documentation and associated release
activities to ensure compliance with applicable
and documents incoming inspections of donor tissues to ensure
compliance with product specifications and applicable regulations
and requirements. Communicates with tissue partners to obtain
additional information as needed.
- Leads and
collaborates on development of Donor Services related Standard
Operating Procedures, Work Instructions, and Forms.
and implements when applicable, with Donor Services process
- Leads in
the collection of donor data and trending and presents data summary
reports to Donor Services Management in addition to providing data
to Quality for Management Review.
- Leads and
performs the donor information sharing, rejection notices, and
donor chart corrections process.
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.
with investigations and documentation related to Donor Services of
CAPAs, Deviations, Nonconformance Reporting, and Complaints, as
directed by Donor Services Management.
- Assists in
releasing batch records for final product distribution.
peers on processes within the Donor Services team and assists with
adherence to Standard Operating Procedures and Work
administrative tasks such as scheduling, filing, organizing
inspections and audits from regulatory agencies, as
Quality functions as designated and trained by Management (e.g.,
Tissue Utilization Records, Environmental Monitoring, Supplier File
Maintenance, Quality Review of records etc.).
with the Supplier Qualification and Control program for Recovery
applicable, performs as needed, the donor tissue acquisition
process including but not limited to:
with physicians on StimLabs protocol for acquiring
donor authorization/donor informed consent, performing donor risk
assessment interview/medical social history questionnaire, offering
services to donors/birth mothers
acquiring, packaging, and shipping donated tissues
degree in a technical/relevant field, with at least three to five
(3-5) years in 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.
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
Job Type: Full-time
Pay: From $65,000.00 per year
- 3-5 years minimum donor chart review
is a regenerative medicine company guided by our desire to innovate
and create optimized healing solutions. By bringing together a
unique set of skills across tissue engineering, pharmaceuticals,
and medical devices, we're reimagining what's possible in
regenerative medicine. Our staff, our quality system, and our
physical workspace were all meticulously selected with the future
is home to some of the top tissue engineers, inventors, and
thought-leaders in the healthcare industry. Combined, these
individuals have more than 100 years of experience in
We're looking for like-minded individuals who are forward thinking,
hard-working, and self-motivated. We pride ourselves in hiring
genuine people who are able to work collaboratively towards our
vision. We have a united culture where everyone from quality and operations to marketing and product
development works together as a
is an Equal Opportunity Employer
Job Posted by ApplicantPro
Keywords: StimLabs, Roswell , Senior Donor Services Specialist, Other , Roswell, Georgia
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