Supports Indiana Blood Center's ability to provide safe, quality products and services by monitoring and supporting the quality assurance program for all operating divisions and departments. Assists in establishing and maintaining an aggressive compliance program to ensure adherence to regulations and standards. Reviews and monitors the quality system, and provides input into the program’s strategic direction. Reviews proposed changes in methods, manufacturing, or instrumentation. Assists in change and project planning and provides interpretation of compliance risks, alternatives or options. Provides input for validation planning. Serves as backup for review and approval of validation plans and summaries.
Reviews, evaluates, and approves standard operating procedures (SOPs) and change control and impact/risk assessment forms. Reviews deviation reports to ensure issues are appropriately investigated, resolved, corrected, and documented. Partners with IBC departments to provide QA support. Identifies, prepares and submits requlatory submissions/notifications as required. Maintains other quality programs as required (equipment, risk, safety)
Four year degree required preferably in Medical Technology (ASCP certified), life sciences, engineering with science minor or an allied health science discipline with three years blood banking or laboratory experience preferred. Certification as a quality auditor, quality manager or lead auditor strongly preferred. Five years supervisory, management or Quality Assurance experience preferred. Experience with delivery of technical and non-technical training material preferred. Understand general workflow and equipment used in a medical laboratory setting. Must have a knowledge of federal, EMEA and state regulations, particularly CFR Title 21, Sections 200 and 600 and Title 42.