Quality Assurance Associate

Central-California-Blood-Center; Fresno (CA); On-site; USD 29,000 - 35,000; Full time

Job summary

Central California Blood Center is seeking a QA-support professional to assist the Quality Assurance Department in maintaining policies, procedures, and regulatory timelines. The role requires strong written and verbal communication, confidentiality, and proficient computer skills, with on-site duties at the Fresno location.

Responsibilities include document control, reporting for FDA deviations, and aiding in license renewals while aligning with the company’s standards and values.

Qualifications

• High School Diploma or GED required.
• 1–3 years working in a healthcare field or blood banking preferred or equivalent.
• Strong writing and proofreading skills.
• Proficient in Microsoft Office, especially Excel.
• Knowledge of federal regulatory/state requirements and accreditation standards preferred.

Responsibilities

• Organize, reconcile, review, route and maintain department documents and records.
• Maintain off-site storage including lists and files, coordinate retrievals.
• Assist with gathering information for Post Donation Information (PDI) reports and QIRs.
• Prepare reporting materials for FDA deviations and notifications within established timeframes.
• Provide routine office support and prepare correspondence.
• Maintain QA calendars and assist with license renewals and audits.

Skills

Writing skills

Customer service

Healthcare terminology

MS Office proficiency

Regulatory knowledge

Time management

Education

High School Diploma or GED

Tools

Microsoft Office

Excel

Job description

Description

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.

Requirements

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 [e-mail].