Quality Assurance Specialist
CurrentReviews SOPs to ensure that the most recently approved SOP procedures and forms are in the center procedure manuals and in use.Complies with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities.Reviews equipment calibration, validation, and maintenance records to ensure they are performed correctly and on time.Reviews freezer and refrigerator charts and temperature records for compliance with SOP.Performs QA review of external sample and product shipment releases and shipping records.Performs QA review of training records to ensure compliance with SOP, training manual and regulations.Performs QA review of deviation reports.Ensures the Donor Center’s licenses and certificates are in-date and valid.Reviews donor record files daily per DCOP instruction.Reviews of all product destruction records for compliance with SOPS.Performs a QA review of reactive donor record files, including look-back records for compliance with SOP.Reviews Quality Control checks on equipment, reagents, and records have been performed as required and are in acceptable ranges.Performs audits for self-assessment evaluation, monitor records, and overall compliance related to the company quality systems.Attends and assists in all audits and ensures that all audits (internal and external) are performed, documented, reviewed, and closed.Assists in maintaining the established quality system under any requirements that affect the center and help ensure that all operations in the center are in compliance with the Company’s Quality Program.Assists in, conducts, and evaluates center training and orientation programs.