Quality Assurance Coordinator

Job Description

Job Description

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.

Responsibilities:

Under the guidance and direction of the Associate 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.
• Other duties as assigned.

Knowledge, Skills and Experience

• 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.

Schedule / Work Hours
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.