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Quality Assurance Associate

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Blood Bank of Hawaii

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Location:
United States , Kapolei

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

22.03 USD / Hour
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Job Description:

Under the direction of the Director of Quality Assurance & Process Improvement, the Quality Assurance Associate (QAA) is responsible for coordinating, monitoring, and facilitating activities within the Quality Assurance department. The QAA supports routine Quality System activities and provides quality consultation related to deviation management, training, document control, process improvement, and implementation of process changes.

Job Responsibility:

  • Product Retrieval and Quarantine: Track, ensure timely completion, and file post-donation information (PDI) reports
  • Initiate PDI reports when necessary
  • Perform active product retrievals and consignee notifications
  • Complete and submit Biological Product Deviation (BPD) reports to the FDA
  • Provide additional support as directed
  • Deviation Management System: Distribute event reports to appropriate departments for investigation and completion
  • Track, ensure timely completion, and file event reports
  • Prepare information for and attend scheduled event review meetings
  • Participate in root cause analysis planning sessions as needed
  • Initiate event management processes and BPD reports when required
  • Provide data and reports for event trend analysis
  • Update Quality Indicators
  • Audits: Coordinate scheduling and data collection for internal audits per audit schedule
  • Distribute audit reports, track responses, ensure timely completion, and maintain audit files
  • Perform non-scheduled audits as directed
  • Assist with preparation of materials for external audits (AABB, EU, Hawaii DOH, CLIA)
  • Maintain files for all internal and external audits
  • Customer Complaints: Distribute customer complaint reports for investigation and follow-up
  • Track, ensure timely completion, and file customer complaints
  • Initiate customer complaint reports when required and provide additional support as directed
  • Regulatory and Educational Records: Track completed training records, including organizational, task, SOP revision, and other required training
  • Provide training status reports for audits, investigations, or departmental review
  • Accompany inspectors during on-site inspections (fixed or mobile sites)
  • Maintain accurate inspection records and prepare inspection reports
  • Assist with regulatory submissions and communications to FDA, AABB, EU, and other agencies as requested
  • Document Control: Maintain document tracking and distribution systems for all BBH documents
  • Ensure document compliance with regulatory and professional requirements
  • Coordinate periodic SOP reviews per regulatory standards
  • Assist with record retention coordination
  • Edit and format procedures and controlled documents as needed
  • Change Control: Assist with project plan development and implementation under the change control system
  • Monitor completion of required documentation throughout project lifecycle
  • Support project managers and teams with documentation
  • Represent QA on project teams as needed
  • Assist with post-implementation effectiveness checks and corrective action tracking
  • Maintain QA change control files
  • Supplier Qualification: Initiate vendor qualification for new suppliers of critical supplies and services
  • Maintain current approved supplier/vendor list
  • Initiate supplier requalification as required
  • Track completion of vendor or manufacturer recall actions
  • Validation: Route validation documents for review and approval
  • Maintain files for completed validation plans, discrepancies, and executed validations
  • Other Duties: Perform other tasks and responsibilities as assigned

Requirements:

  • Bachelor’s or Associate’s degree in a science-related field, or two (2) years of equivalent experience in an FDA-regulated industry
  • Knowledge of medical terminology preferred
  • Knowledge of FDA, HIOSH, and OSHA regulations
  • Three to four (3–4) years of experience in a blood bank, clinical laboratory, or other regulated industry preferred
  • Strong oral, reading, and written communication skills
  • Ability to gather, investigate, and compile information into written reports
  • Detail-oriented with strong accuracy and ability to learn quickly
  • Ability to troubleshoot teleconferences
  • Strong organizational and time management skills with ability to multitask
  • Excellent interpersonal and customer service skills
  • Ability to work independently and collaboratively as part of a team
  • Adherence to Good Documentation Practices (GDPs)
  • Proficient in Microsoft Office (Outlook, Access, Word, Excel)
  • Strong data management and reporting skills
  • Professional, business-like demeanor
  • Reliable attendance
  • Flexible schedule to meet deadlines
What we offer:
  • 100% Health, Dental, and Vision Insurance
  • Matching 401(k) Plan
  • Paid Time off
  • Career Development and Training
  • Opportunities for Promotion

Additional Information:

Job Posted:
February 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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