Quality Specialist QA/QC/Donor Services StimLabs - Roswell, GA 30076 Provides key Quality support to the StimLabs organization * Acts as a quality representative within the organization, raising awareness for quality standards and education * Contributes to the development of quality-related infrastructure for new products * Assists on a variety of projects and participates in daily Quality activities * Suggests and assists with continuous improvement projects within the Quality System * Responsible for activities and documentation related to Donor Services and Donor Eligibility Participates in daily operations of the Quality department * Assists with records management and the Document Control system * Assists with incoming inspection and release of all raw materials (including donor tissue), components, sterilized bulk product, and supplies * Assists with in-process and finished product Quality inspections of materials and products to ensure compliance with product specifications and regulatory requirements * Collaborates on development of SOPs, Work Instructions, Forms, sampling plans, and specifications * Reviews and maintains documentation and records associated with equipment and facility/environmental monitoring, all processing forms requiring Quality review * Assists with the Supplier Control program for company-wide providers * Reviews biological indicators from sterilization cycles to ensure sterilization cycle parameters and specifications were met * Assists with investigations and documentation of CAPAs, Deviations, Nonconformance Reports, and Complaints, as directed by the Quality Manager * Support inspections and audits from regulatory agencies, as needed * Reviews and prepares Donor Charts and batch records to ensure compliance with applicable regulations and requirements * Participates in Donor Eligibility program through the review of donor charts, infectious disease testing results, procurement culture results, communication with Recovery Partners for donor chart corrections, and preparation of the donor chart for final eligibility review by the StimLabs Medical Director. * General administrative tasks such as scheduling, filing, organizing etc. * Support inspections and audits from regulatory agencies, as needed EDUCATION/CERTIFICATION Bachelors degree in a technical field, with at least one to two (1-2) years of Quality Assurance and/or Quality Control experience in a tissue bank, biologic, medical device, pharmaceutical, or FDA regulated facility; or an appropriate combination of education and work experience. REQUIRED KNOWLEDGE 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 processing of donor tissue preferred but not required. Job Type: Full-time Education: * Bachelor's 7 hours ago - save job