Quality Assurance Specialist

About Us:

At Blood Bank of Hawaii, your work directly impacts lives across our community. As a Quality Assurance Specialist, you’ll play a critical role in ensuring the safety, compliance, and continuous improvement of our blood services. If you’re detail-oriented, analytical, and passionate about quality in healthcare, this is your opportunity to make a meaningful impact.

Position Summary

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.

Benefits:

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

Job Duties & Responsibilities:

• 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

Education & Knowledge

• 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

Required Licenses/Certifications

• Valid driver’s license with a clean driving abstract

Experience

• 3–4 years of experience in a blood bank, clinical laboratory, or regulated industry preferred
• ASQ certification (CQIA, CQPA, or higher) preferred

Skills

• 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)

Additional Requirements

• Professional and dependable with strong attendance
• Flexible schedule to meet business needs and deadlines
• Ability to travel or drive to mobile operations as needed

Schedule:

• 8-hours Shift
• Day Shift
• Monday to Friday
• Weekends as needed

Expected hours: 40/hours per week

Job Type: Full-time

Location:

• Blood Bank of Hawaii – Kapolei Headquarters
• 2212 Lauwiliwili Street, Kapolei, HI 96707

Pay: $22.03 per hour

Experience:

• clinical laboratory, or regulated industry: 3 years (Preferred)

Location:

• Kapolei, HI 96707 (Preferred)

Ability to Commute:

• Kapolei, HI 96707 (Required)

Willingness to travel:

• 75% (Required)

Work Location: In person

Salary : $22