Quality Assurance Specialist Job Heartland Blood Centers Auroraby admin on more than 30 days
Heartland Blood Centers Job Vacancies 2020Description :
Under the direction of
the Director, Quality, support’s the blood center’s ability to provide safe,
quality products and services by supporting the overall Quality Management
System and quality assurance program for the Blood Center.
DUTIES AND RESPONSBILITIES
Review and approve standard operating procedures, validation plans and
results, corrective action plans associated with audits and events, and other
required documents for compliance as required.
Identifies emerging events in blood center operational departments, and
participates in assessment of product, donor, patient, regulatory risk and/or
Communicates applicable regulatory and accreditation changes to
departments (i.e. federal register notices, guidance documents, etc.).
Assists operations with review of proposed changes in methods,
manufacturing, or instrumentation.
Develops, compiles, and submits regulatory submissions as required.
Assists with external inspections as assigned, and facilitates optimal
communication between the department and the inspector/assessors.
Review, analyze, approve, and monitor events logged in event management
system, including adequacy of investigation, quality of documentation, and
appropriateness of corrective and preventative actions.
Evaluates current processes to Identify trends and potential problems
proactively before products or patients are affected. Work with departments to effectively
avoid/eliminate potential problems.
Conduct problem surveillance (event reports, audit deficiencies,
customer complaints, supplier recalls, etc.
Work with departments to effectively resolve problems.
Perform review of nonconforming products. Participate in decisions to determine blood
and component suitability for use, distribution, or recall.
Perform audits of operational departments, serve as lead auditor, and
prepare final report of audit outcome within required timeframe. Monitors completion of corrective actions.
Supports organizational and department projects from a regulatory and
quality perspective, and completes assigned tasks in a timely manner.
Acts as consultant/resource for regulatory and quality matters.
Provides critical feedback directly to departments regarding their state
Assists with product recall as required.
Ensures that departments comply with Quality Management System.
Assists in the development and implementation of training provided by
of Science Degree in Clinical Laboratory Science, life sciences, engineering
with science minor, scientific discipline, or allied health science discipline.
experience in a technical or quality/regulatory support capacity for a blood
center, laboratory, or transfusion service preferred.
conducting audits preferred.
with technical writing preferred.
interpersonal, verbal and written communication skills, including the ability
to communicate technical information to colleagues at all levels in the
ability to read, interpret, and apply regulations and standard applicable to the
activities performed at the blood center.
knowledge of current good manufacturing practices and procedures; quality
principles, theory and tools, as well as basic auditing principles.
knowledge of current federal, state, local regulations and guidelines
applicable to the operations of the blood center.
knowledge of quality management systems.
to effectively lead/manage projects in a team setting.
knowledge of continuous improvement methods and tools.
to apply quality tools such as process mapping, root cause analysis and FMEA.
to work independently, prioritize, manage, and complete multiple tasks within
designated deadlines, often requiring shift in priorities with little advance
in technical writing, project planning, and validation preferred.
analytical and problem solving skills.
attention to detail.
skills with the ability to conduct training and education sessions preferred.
in Microsoft Office applications, as well as the ability to learn and
effectively use other computer software as required.
state driver’s license.
Should you meet the qualifications required, please register and apply to Heartland Blood Centers website with link as follow :
Please note that we do not accept any CV submissions. If You want to apply for a job that you have discovered on karomall.com, simply click on the provided job application link and follow the instructions afterwards. You'll be taken to a more detailed page.