Senior Quality Assurance Specialist, Donor Eligibility in South Miami, Florida at OrganaBio, LLC

OrganaBio was founded in 2018 with the mission to become the hub for tissue sourcing, clinical sample processing and contract manufacturing services to support cell and gene therapy developers around the globe. At our core, we continually apply a data-driven approach with meaningful insights across our strategically located facilities to provide solutions to our clients where they need it most. Headquartered in Miami, Florida, OrganaBio delivers products and services that span the full development lifecycle – from proprietary tissue supply chains and cellular starting materials to expert development, testing, and other support services that expedite the path to clinical translation.

The Senior Quality Assurance Specialist, Donor Eligibility facilitates tissue supply chain operations by verifying donor eligibility and maintaining required donor documentation. This role is responsible for overseeing blood and tissue collection operations to ensure compliance with established procedures, standards, and regulations. The Sr. QA Specialist partners with functional groups as the point of contact for quality issues associated with donor operations and fosters continuous improvement of blood and tissue supply chain operations.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

• Serves as the primary QA point of contact for all donor and collection quality-related issues.
• Verifies and documents donor eligibility and approval to participate in blood and tissue donation programs.
• Works cross-functionally to ensure the timely release of tissue-related products.
• Approves and issues labels, lot numbers, conditional and final C of A in support of product release.
• Monitors donor engagement activities and tissue collection operations to ensure compliance with internal procedures and applicable regulations.
• Performs timely reviews of donor charts, informed consents, donor history questionnaires, and related donor documentation.
• Interacts with Medical Director on donor history questionnaires, and related donor documentation eligibility questions as applicable.
• Reviews and approves donor deferral documentation.
• Manages donor enrollment databases and tracks donor participation.
• Writes, revises, and implements regulatory-compliant quality policies and procedures.
• Trains staff on quality-related processes and procedures, including annual compliance training.
• Ensures controlled issuance, distribution, retrieval and archival of controlled documents and records.
• Verifies, issues, and ensures reconciliation of product and sample labeling.
• Facilitates internal audits of tissue supply chain operations.
• Conducts and documents complaints, adverse events, deviations, and investigations, as needed, and ensures successful completion of associated CAPAs.
• Assists in the development of material specifications, ensures material CoA/CoC documentations is available, and performs release of incoming raw materials.
• Ensures new and existing physicians are appropriately onboarded and all required documentation is on file and current.
• Manages and maintains donation program documentation.
• Author, review, and execute equipment and instrument validations.
• Prepares annual donor reports for submission to IRB.
• Assists in the facilitation of partner/customer audits and regulatory inspections.
• Participates in supplier audits, as needed.

• Other related duties as assigned.

• Consistently sets a high standard for quality of work.
• Comfortable with working in a fast-paced and dynamic start-up environment.
• Ability to work flexible hours to meet business and/or customer needs.
• Excellent interpersonal, organizational, communication and listening skills.

Education: Bachelor’s degree in science or equivalent industry experience.

Experience: 5+ years of experience working in a GxP environment or other regulated industry. Prior experience in a donor-focused quality role, strongly preferred. Experience with blood banking, apheresis, whole blood, placenta, umbilical cord- and cord blood-derived products is preferred. Experience supporting internal, regulatory, and partner audits is preferred.

Computer Skills: Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams. Familiarity with electronic documentation systems a plus.

Other Requirements: Familiarity with cGTP and cGMP requirements, specifically 21CFR 606, 630 and 1271, as well as AABB and AATB requirements. AABB and/or AATB certification is preferred. CPR training is preferred. Must be fully vaccinated; Hep B.