An internationally known leader in transfusion medicine, we provide a safe and adequate supply of blood components and related services to individuals, health care organizations and communities. Dedicated to serving the public interest, we achieve our mission by upholding medical, ethical, regulatory and professional standards, and by supporting research in the fields of blood services and transfusion medicine.
Under minimal direction, this position is responsible for review of the quality systems and compliance in all areas of technical and clinical operations. Participates in operational excellence and other performance improvement initiatives. Oversees staff participation in performance improvement initiatives to include data and process analysis. Serves as a resource to operations on quality issues.
DUTIES AND RESPONSIBILITIES:
Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
Assures quality customer service to all customers.
Maintains good attendance and punctuality per the absence policy.
Provides effective leadership to achieve high levels of service and product quality, financial results, and other criteria in accordance with policies, goals, and objectives.
Hires, supervises, trains, develops, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues.
Conducts data and process analysis activities including in-depth analysis of deviation and operational performance data. Evaluates data for trends and opportunities for improvement and communicates this to operations management.
Ensures deviation management reports are accurate and timely and that events are coded correctly. Facilitates root cause analysis, reviews and approves corrective action, and performs effectiveness evaluations.
Participates in improvement initiatives and the use of improvement tools and methodologies. Serves as an improvement resource to operations.
Evaluates process change to include data collection and risk identification. Assists with development of risk mitigation steps.
Hosts external inspections. Assists in facilitating responses to observations. Ensures corrective actions were implemented and effective. Conducts risk assessments.
Supports the internal audit program and the performance of process based audits. Assists operations in evaluating observations, performing investigations, and conducting root cause analysis, and the development of corrective action. Performs follow-up on audit observations. Tracks responses, monitoring implementation, and ensures effectiveness of corrective action.
Participates on the review team to evaluate nonconforming products, materials, or test results and assesses impact on external customers. Ensures required actions are implemented.
Facilitates recalls and market withdrawals.
Assists in oversight of clinical study or research activities.
Coordinates staff review of documents to ensure processes are within control (e.g., QC data, validations, proficiency testing).
Participates in annual budget preparation and ensures adherence to approved department budget.
Performs all other duties, at the discretion of management, as assigned.
Bachelor's degree required.
Certification as a Medical Technologist or Specialist in Blood Banking (SBB) by a recognized certifying agency or RN licensure preferred.
Five years of related experience in a regulated industry required. To include:
Two years of supervisory experience.
Three years of experience in quality, regulatory, and/or auditing.
Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
Must be able to maintain confidentiality.
Must have analytical, statistical, personal organization, and problem solving skills.
Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate senior and executive-level managers.
Effective oral and written business communication skills.
Able to organize, prioritize, and execute a variable workload and multiple priorities.
Must have proficient computer skills.
Internal Number: 181075
About Blood Systems
Blood Systems is an internationally known leader in transfusion medicine founded on the principles of quality, excellence and service. Our headquarters are located in sunny Scottsdale, Arizona.
Founded in 1943 as the Salt River Valley Blood Bank in Phoenix, Arizona, today Blood Systems is one of the nation’s oldest and largest non-profit transfusion medicine organizations.
The Blood Services division, our largest, provides leadership, policy and shared services to its blood centers. It facilitates comprehensive blood service contracting for national and regional healthcare systems. Our blood centers provide blood, blood components and special services to patients in some 1,000 hospitals across the country.
Blood Systems Research Institute generates and analyzes data to aid the US and worldwide transfusion community by recommending testing strategies and technology. Creative Testing Solutions, a joint venture, is the largest independent blood donor testing organization in the country with several high volume laboratories. The BioCARE division distributes therapeutic biologicals and recombinant coagulation factors, including such products as albumin, coagulation factors, fibrin sealants, IVIG and Rh immune globulin. Our CanyonCARE Rx specialty pharmacy is part of BioCARE.