Quality Assurance Coordinator

Summary Statement

The Quality Assurance Coordinator assists the Chief Quality and Compliance Officer with oversight of the Quality Management System, (QA/QC, cGMP, cGTP, and cGLP) ensuring that systems and procedures are compliant with applicable federal and state laws and regulations and accreditation standards.

Under the guidance and direction of the Director, Quality Assurance and Regulatory Compliance, the Quality Assurance Coordinator shall:

• Assist in promoting and maintaining a quality culture throughout the organization.
• Conduct internal audits of WU and CT/ET donor charts and apheresis collection charts.
• Ensure all department training is up to date and assign new training, as needed.
• Assist with investigation and resolution of deviations, complaints and adverse reactions, as needed
• Maintain QA related documents and reports.
• Participate in continual improvement activities to enhance the Quality Management System across all departments (Donor Services, Apheresis Center, Cellular Therapy Laboratory and Gift of Life Biologics).
• Develop a working knowledge of all areas of the organization and a clear understanding of the organization’s key functional processes and resources.
• Fulfill other duties as assigned.

• 1-3 years of experience in Quality Assurance
• FDA cGMP(21 CFR 210 & 211) and CGTP(21 CFR 1271) regulations
• Must be detail-oriented and demonstrate good documentation practices.
• Demonstrate ability to manage and prioritize multiple projects and meet deadlines.
• Possess strong oral and written customer service and communication skills. Must be able to remain calm and tactful when resolving problems involving all levels of staff, visitors, vendors, etc.
• Adept at problem-solving and decision-making.
• Flexible and adaptable to changing conditions.
• Good project management skills.
• Knowledge, training and experience in QA principles and data management systems.
• Evidence of understanding and monitoring of compliance with SOPs.
• Proficient in Microsoft Office Suite and other data management software.
• Good time management, organizational skills and ability to set priorities.
• Demonstrated ability to work independently as well as part of an integrated team.

The hours for this position are 40 hours per week and are fully in office. Employees may work either a 4-day, 10-hour schedule or a 5-day, 8-hour schedule.