- Roswell, GA, USA
- Full Time
Medical , Dental, Vision, FSA, HSA, Short Term Disability, Long Term Disability, Life Insurance, Telehealth, 401k and more.
KEY DUTIES AND RESPONSIBILITIES
Provides leadership within the StimLabs organization:
- Manages daily activities of Donor Services Chart Review including scheduling and coordinating activities to meet company objectives.
- Leads in implementing improvements within the Donor Services System and department.
- 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.
- Leads on a variety of projects as designated by Donor Services Management.
- Member of StimLabs Internal Audit Team.
- Conducts all activities and documentation related to Donor Eligibility.
- Collaborates on hiring of new Donor Services department staff.
Participates in daily operations of the Donor Services department including but not limited to:
- Manages and assists with department review of donor eligibility documentation and associated release activities to ensure compliance with applicable procedures.
- Leads and collaborates on development of Donor Services related Standard Operating Procedures, Work Instructions, and Forms.
- Performs collection of donor eligibility data and trending of donor chart information such as backlog, to report to the Director of Donor Services.
- Assists and collaborates with the Director of Donor Services in building tools to streamline efficiency in donor pre-eligibility determination efforts.
- Assists with donor information sharing, rejection notices, and donor chart corrections process.
- Manages and assists with 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.
- Manages intradepartmental and tissue partner communications and troubleshoots as a liaison to ensure information is received or sent in a timely manner.
- Provides support in helping Donor Services Document Control Specialists as part of the escalation process for critical information.
- Assists with investigations and documentation related to Donor Services of CAPAs, Deviations, Nonconformance Reporting, and Complaints, and being the designated person to sign off and close reports as directed and trained by Donor Services Management.
- Leads the training efforts with the DS Management for the Donor Services team on donor eligibility processes within the Donor Services department with adherence to Standard Operating Procedures and Work Instructions.
- General administrative tasks such as scheduling, filing, organizing etc.
- Assists with other Quality functions as designated and trained by Management (e.g., Tissue Utilization Records, Environmental Monitoring, Quality Review of records etc.).
- Support inspections and audits from regulatory agencies, as needed.
Bachelor's degree in a technical/relevant field, with at least eight plus (8+) years leading 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.
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.