Quality Assurance Associate

FLSE Status: Non-exempt

Employment Type: Regular Full Time

Reports To: Quality Assurance Director

Pay Range: $21.25-$25.57/hourly

Schedule: 35+ hours (occasional weekends and holidays to meet operational needs)

Location: Jenny Eller Donor Center- Fresno, CA

Job Summary:

The primary responsibility of the position is to support the Quality Assurance Department in maintaining organizational policies and procedures, and meeting federal regulatory and state timelines. Must be able to perform each major job duty satisfactorily and work independently with little to no supervision, have strong written and verbal communication skills, maintain confidentiality, computer background in word processing and spreadsheets and possess excellent time management skills.

Essential Job Duties:

· Responsible for daily organizing, reconciliation, review, routing and maintenance of all department documents, records, logs, spreadsheets and forms

· Responsible for maintaining CCBC off site storage including lists, records, filing, and coordinating retrieval/sending of department boxes

· Assists with gathering information for Post Donation Information (PDI) reports and QIR’s

· Compiles files and information for timely reporting of all Blood Product Deviations to FDA, consignee notifications and fractionator notification within established timeframes

· Serves as a QA reviewer of Laboratory Look Back notifications

· Assists with and maintains current licenses for blood center and assures that they are renewed within established time frames

· Participates in review of manufacturing data for compliance to internal procedures and provides audit reports for department notification

· Provides routine office support (i.e. making copies, sorting and filing documents, preparing correspondence and picking up correspondence

· Prepares letters for Component Quarterly Reports and mails documents to area hospitals.

· Updates QA department historical calendar as needed

· Maintains and meets quality and productivity per department standards(policies/procedures)

· Serves as a back-up to the Quality Assurance Specialist as needed

· Demonstrates alignment with and adherence to the company’s core values in all interactions, decisions, and work activities; serves as a role model for fostering a positive, respectful, and ethical workplace culture

· This position requires consistent, on-time attendance in accordance with company policy. Excessive tardiness or absenteeism may impact performance and employment status.

· Employees in this role are entitled and expected to take compliant meal and rest periods in accordance with California law.

Note: The duties and responsibilities described above are not a comprehensive list and that additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands.