Quality Assurance Specialist Job at Blood Bank of Hawaii (Kapolei)

Quality Assurance Specialist

Blood Bank of Hawaii

Location:
United States , Kapolei

Category:
Health and Beauty

Contract Type:
Employment contract

Salary:

22.03 USD / Hour

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Job Description:

Under the direction of the Medical Director and Quality Assurance Supervisor, the Quality Assurance Specialist (QAS) supports and maintains Quality Systems across the organization. This role is responsible for coordinating QA activities, ensuring regulatory compliance, supporting process improvements, and guiding teams through investigations, audits, and change management.

Job Responsibility:

Investigate, complete, and submit Post Donation Information (PDI) and Biological Product Deviation (BPD) reports, including FDA submissions, product retrievals, and notifications
Evaluate, categorize, and track quality events
lead and facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA), ensuring timely resolution
Initiate and manage event reporting processes
prepare and participate in meetings related to investigations and quality events
Track, trend, and analyze data to identify recurring issues
generate reports and lead investigations for continuous improvement
Plan, conduct, and follow up on internal audits
support external audits (FDA, AABB, DOH, CLIA) including preparation and gap assessments
Ensure organizational compliance with FDA regulations, AABB standards, SOPs, and regulatory updates
Review reports, records, and documentation for accuracy, completeness, and compliance
monitor and maintain quality systems
Review and support training programs to ensure compliance with regulations and standards
assist with cGMP and cGTP training and competency assessments
Participate in inspections, document findings, and communicate results to leadership
assist with regulatory submissions and communications
Maintain document control systems, SOP reviews, and regulatory record retention requirements
Develop and update procedures, processes, and controlled documents related to QA systems
Support and oversee change control processes and project implementation
ensure proper documentation and compliance
Participate in cross-functional teams and represent QA
perform post-implementation effectiveness checks and track corrective actions
Assist with vendor qualification, supplier monitoring, validation activities, and product recalls
Lead and support process improvement initiatives, using quality tools (e.g., Fishbone, Pareto, process mapping)
Monitor effectiveness of process improvements through audits, data tracking, and reporting
Review customer feedback and donor-related concerns
initiate and support complaint investigations
Perform other duties as assigned

Requirements:

Bachelor's degree in a science-related field or equivalent experience in an FDA-regulated industry preferred
Knowledge of FDA, AABB, HIOSH, and OSHA regulations preferred
Medical terminology knowledge, but not required
Valid driver’s license with a clean driving abstract
3–4 years of experience in a blood bank, clinical laboratory, or regulated industry preferred
ASQ certification (CQIA, CQPA, or higher) preferred
Strong written and verbal communication skills
able to present clear, fact-based information
Effective listening and investigative skills with ability to compile detailed reports
Strong analytical, problem-solving, and critical thinking abilities
Detail-oriented with strong accuracy and ability to learn quickly
Excellent organizational and time management skills
able to multitask under deadlines
Strong interpersonal and customer service skills
able to work with diverse teams and leadership
Ability to work independently and collaboratively
Proficient in Microsoft Office (Word, Excel, Outlook)
Basic troubleshooting skills (including virtual/teleconference support)
Professional and dependable with strong attendance
Flexible schedule to meet business needs and deadlines
Ability to travel or drive to mobile operations as needed

What we offer:

100% Health, Dental, and Vision Insurance
Matching 401(k) Plan
Paid Time off
Career Development and Training
Opportunities for Promotion
SAVING LIVES EACH DAY

Additional Information:

Job Posted:
April 23, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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