Assures the Donor Center(s) complies with all applicable state, federal, and European Union
guidelines.
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Direct responsibility for the day-to-day activities, evaluation, and training of the Quality
Assurance Specialist.
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Authorizes the release of final product and has the authority to stop shipment of any product
that does not meet compliance or customer specifications.
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Assures accurate labeling and documentation of shipments.
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Assures center maintains state of readiness for regulatory and customer audits.
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Responsible for tracking and trending errors, corrective actions, and the approval of
preventative action.
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Reports compliance status to Center Management and Regional Quality Assurance Manager
routinely.
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Assures accuracy of electronic donor records in the applicable donor center system.
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Assures all supplies and materials meet quality regulations prior to placement into use.
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Monitors and ensures the maintenance and calibration of equipment is completed and
documented as required by procedures.
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Ensures completion and accuracy of training for new employees, competency training of
existing staff on an annual basis, and training records.
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Maintains competence with all position required tasks.
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Maintains the center compliance monitoring system to assist in the identification of risk
areas.
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Attends and actively participates in Plan, Do, Check, Action meetings.
Core Competencies/Behaviors:
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Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs.
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Oversees execution, documentation, and review of internal and external audits.
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Actively provides feedback to operations management and staff regarding staff performance
against SOPs. Works to develop and maintain a collaborative and effective working
relationship with operations management.
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Responsible for ensuring the center meets all regulatory and quality timelines as established
in SOP documents.
Compliance Requirements (ES):
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Has the responsibility to report any deviations (GMP) or regulatory practices to the Regional
Quality Assurance Manager.
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Assures that SOPs, policies, and practices are updated and validated as applicable and that