Senior Quality Assurance Specialist, Donor Eligibility

OrganaBio • South Miami, FL

1h

About The Position

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.

Requirements

• Bachelor’s degree in science or equivalent industry experience.
• 5+ years of experience working in a GxP environment or other regulated industry.
• Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.
• Familiarity with cGTP and cGMP requirements, specifically 21CFR 606, 630 and 1271, as well as AABB and AATB requirements.
• Must be fully vaccinated; Hep B.

Nice To Haves

• 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.
• Familiarity with electronic documentation systems a plus.
• AABB and/or AATB certification is preferred.
• CPR training is preferred.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior