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 QIRs

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 companys 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.

Qualifications and Skills

Education/Licenses/Experience

High School Diploma or GED required

One to three years working in a healthcare field or blood banking industry preferred or an equivalent combination of education and experience may be considered

Skills

Competent writing skills with solid grammar and proofreading experience

Professional phone and customer service etiquette

Healthcare or medical terminology knowledge preferred

Excellent computer skills utilizing Microsoft Office proficient in Excel or other data management tools including data presentation preferred

Knowledge of organizational policies and procedures federal regulatory and state requirements and/or current accreditation standards preferred

Consistent with the Americans with Disabilities Act (ADA) and state of California Civil Rights Law it is the policy of Central California Blood Center to provide reasonable accommodation when requested by a qualified applicant or employee with a disability unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment including the application process. If reasonable accommodation is needed please contact the Human Resources Department at