Under minimal supervision, this position is responsible for providing management with an independent assessment of operations through reporting of internal audit results for Employer and business units. This position drives the organization's internal auditing program to ensure compliance with applicable standards, regulations, and internal specifications and to measure the effectiveness of the quality system. This position serves as a resource to quality and operations for compliance 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.
Plans, organizes, leads, and monitors the organization's internal audit program for multiple locations over a large geographic area according to current auditing principles, regulatory requirements, and best practices.
Develops and oversees the annual internal audit schedule for all operating unit compliance audits in conjunction with local quality and operations staff. Ensures adequate coverage for operating units engaged in any or all parts of the manufacturing process (recruitment through distribution).
Provides guidance and consultation in the development of audit work tools for all areas of technical and clinical operations, as needed. Reviews documents for relevance and accuracy, as needed.
Prepares audit scope and independently increases or decreases processes and areas to be audited based on operating unit and system compliance performance. Collaborates with local quality and operations staff to identify areas of concern and assess needs for an audit team.
Performs multiple operating unit internal audits to ensure compliance. Collaborates with team members on work assignments. Assembles audit teams, assigns responsibilities, and provides guidance and work coordination to the audit team members.
Analyzes audit evidence gathered independently or by team members. Prepares final audit reports and communicates audit outcomes to local management, quality staff, and corporate management. Synthesizes data and reports from multiple audits to identify issues that may warrant further audit oversight or verification.
Assists with presentation of internal audit summaries on system-wide project teams and at management meetings as needed. Monitors overall effectiveness of the auditing program. Initiates corrective actions with Executive Management, as needed. Participates in Six Sigma and other performance improvement initiatives as needed.
Provides interpretation and guidance of national and international regulations, standards, and Standard Operating Procedures to Employer and business units as they relate to audit observations.
Remains abreast of changes and developments in the blood banking industry related to regulations and standards. Provides direction to implement required changes. Establishes and maintains a network of professional relationships.
Leverages information gained from audits related to critical processes to identify risks as well as to promote standardization throughout the organization. Performs all other duties, at the discretion of management, as assigned.
Bachelor's degree required.
Knowledge of blood banking industry standards and regulations required.
CQA certification preferred.
Certification as a Medical Technologist or Specialist in Blood Banking (SBB) by a recognized certifying agency or RN licensure preferred.
Five years related experience in a regulated industry required. To include:
Three years in a quality, regulatory, and/or auditing environment required.
Experience in the healthcare, blood banking, or pharmaceutical industry preferred.
Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
Must be able to maintain confidentiality.
Must have analytical, statistical, person organization, and problem solving skills.
Ability to work in a team environment and participate as an active team member.
Must have proficient computer skills.
Effective oral and written communication skills.
Ability to organize, prioritize, and execute a variable workload and multiple priorities.
Ability to travel (65 %).
Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail Employer or call 1-844-###-#### to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.
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All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines.