The QA Director is responsible for developing, implementing, and monitoring a sound Quality Assurance Program for Shepeard Community Blood Center (SCBC). The primary responsibility is to ensure that the organization meets all regulatory requirements for collecting, manufacturing, and distributing blood products.
Impact Lives: Ensure the safety and quality of blood products that save lives every day.
Leadership Role: Guide and support operational leaders in compliance and quality assurance.
Innovative Environment: Use your expertise to solve problems and advance business goals in safety, collections, finance, and efficiency.
Regulatory Compliance: Serve as the subject matter expert in federal and state laws, regulations, and accreditation standards.
Support Leaders: Provide guidance and interpretation of regulations and standards to operational leaders.
Problem Solving: Use your regulatory knowledge to proactively advance business goals.
SOP Oversight: Collaborate with senior leadership to review SOPs, validations, maintenance, storage, and other processes.
Reporting: Ensure timely and proper reporting of activities, including product recalls, annual reports, and licensure submissions.
Document Management: Lead the implementation, maintenance, and refinement of a document management system.
Error Investigation: Develop procedures for investigating, evaluating, correcting, following up, and reviewing all reported errors and non-conformities.
Training Oversight: Review and provide oversight of training and competency programs in collaboration with department directors.
Equipment Management: Review equipment qualification, validation, maintenance, and calibration procedures.
Stewardship: Embody a culture of stewardship for donations and their life-altering impacts.
Record Review: Oversee record review and coordinate site inspections (FDA, AABB, etc.), monitor follow-up, and provide corrective actions.
Staff Training: Assist in training and instructing SCBC staff in compliance and quality assurance.
Strategic Planning: Work with the leadership team to complete the strategic plan and advance the mission and vision of the organization.
Shepeard Community Blood Center is a 501 (c) 3 non-profit blood center. Our mission is to collect, process, and distribute blood and blood products. We are the contracted provider for 23 hospitals in 30 counties across the two-state area. We partner with donors, the local volunteer blood donor, to fulfill our mission.