Quality Assurance Specialist - Transplant Lab, Full-Time, Days

At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you'll have the opportunity to join our quest for better healthcare, no matter where you work within the Northwestern Medicine system. At Northwestern Medicine, we pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, we take care of our employees. Ready to join our quest for better?

The Quality Assurance Specialist reflects the mission, vision, and values of NM, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.

The Quality Assurance Specialist works with the Cell Therapy Laboratory Director, Operational Manager, and Quality Manager to assure regulatory compliance of department activities. 

This individual must have excellent written and oral communication skills and proven ability to work independently with minimal supervision. The candidate must be detail oriented. Individual must have the ability to review and maintain metrics and perform quality audits. The position requires proficiency with MS office applications as well as internet/intranet use. The variable nature of the work performed requires demonstrated problem-solving capabilities. The individual must possess high moral and ethical standards.

Responsibilities:

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• Assists Quality Manager in maintaining the Quality Management System (QMS) relative to the technical evaluation and improvement of services in relation to physician and patient care requirements
• Documents all significant activities and recommends corrective action and improvements, as necessary.
• Facilitates compliance with all federal, state, local, JCAHO, FACT, ISO, NMDP, NCCLS, multi-disciplinary, hospital regulations, policies and procedures. Reports significant events to JCAHO, FDA and NM management and Medical Directors as required.
• Assists Quality Manager in maintaining a current QMS Plan and current Standard Operating Procedures (SOPs), guidelines, standards and records.
• Assists Quality Manager in facilitating departmental preparations for accreditation inspections.
• Assists Quality Manager in maintaining a robust Quality Assurance Program that addresses batch disposition, deviation, investigation and corrective action.
• Reviews and catalogs departmental Incident Reports, Quality Improvement Reports and Critical Incident reports.  Prepares regular reports regarding tracking and trending of quality issues, and presents the findings to appropriate management personnel.
• Participates in the efficiency and effectiveness of all on-site quality system activities
• Prepares agendas and creates meeting minutes for department and hospital quality meetings.
• Participates in ongoing quality data collection, which enables monitoring of testing systems. 
• Maintains knowledge and utilizes appropriate resources to provide consultative, educational, technical, or informational services as needed to self, staff or patients.
• Participates in departmental supply recalls in accordance with regulatory requirements.
• Assists Quality Manager in departmental operation audits and communicates results to department management.
• Conducts internal audits.  Evaluates and prepares reports recommending improvements in process and workflow for laboratory sections.
• Assures that responses to audits, both internal and external, are well documented.
• Reviews and approves production batch records
• Assures that research activities performed in the department are in compliance with Hospital Research policies.
• Participates in maintenance of departmental quality, accreditation and regulatory records.
• Additional Functions
  • Participates in and presents at laboratory meetings and continuing education programs.
  • Participates in hospital quality and safety meetings as assigned.
• Communication/Problem Solving
  • Adheres to Patients First Management standards on communication and visibility.
  • Facilitates effective interdepartmental communication of incidents with appropriate personnel (Manager, Administrator, Medical Staff; etc.).
  • Promotes philosophy and objectives of the Hospital, Division and Department.
  • Identifies and communicates key issues and trends to Quality Manager.

Required:

• A bachelor’s degree in a laboratory science or equivalent, such as medical technology/clinical laboratory science, biology, microbiology, molecular biology, chemistry, and biochemistry

Preferred:

• Experience with quality systems
• Previous work experience in the field of cellular therapy product processing
• Knowledge of FDA, FACT, ISO, NMDP. IDOT, CMS, CLIA, JCAHO and NCCLS Standards

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Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.