- Roswell, GA, USA
- Full Time
Medical , Dental, Vision, FSA, HSA, Short Term Disability, Long Term Disability, Life Insurance, Telehealth, 401k and more.
Provides key Donor Services support to the StimLabs organization
- Participates in Donor Services daily activities.
- Suggests and implements 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.
- Assists 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 Chart compilation.
Participates in daily operations of the Donor Services department including but not limited to:
- Performs 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.
- Assists with collaboration of Donor Services related Standard Operating Procedures, Work Instructions, and Forms.
- Performs quality assurance review of documents related to tissue receipt, inspection, and release.
- Assists in performing and documenting investigations, where applicable, relating to donor tissue receipt and inspection.
- Assists as designated by Donor Services Management with Donor Services projects.
- Performs donor information sharing, rejection notices, and where applicable, donor chart corrections process.
- Data entry and maintenance of Tissue Utilization Records.
- 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.
- Is proficient in using electronic systems to trace all activities relating to donor tissue receipt and inspection as well as donor chart compilation.
High school diploma with either tissue banking, medical device, biotechnology, or pharmaceutical industry experience or appropriate combination of education and experience, one (1) year industry experience in quality inspections is required. Experience in communication at all levels, meticulous, and self-motivated. Requires proficient Microsoft Windows experience (MS Excel, Word, PowerPoint, Outlook, etc.).
Knowledge and understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations. Inspection experience in a cGMP regulated environment a plus.