Quality Systems Specialist

Job overview

The Quality Systems Specialist role is onsite at the Blood Bank of Alaska’s main campus in Anchorage, AK. Compensation is not specified. The position is part of the Quality Assurance team and supports the blood bank’s quality processes and assessments. The specialist promotes regulatory and accrediting compliance by investigating occurrences, conducting internal audits, and facilitating procedure changes. This work helps maintain reliable quality systems, support inspections and reporting, and uphold the organization’s quality objectives and customer service standards.

What you'll do

• Promote compliance with accrediting agency, state, and federal regulations
• perform occurrence investigations, including Occurrence Reports, Post Donation Information, Biological Product Deviation Reports, and Quarantine and Lookback for positive test results
• assist with FDA reports, correspondence, and product licensing
• develop audit plans, conduct audits, write reports, and issue findings to department management
• support external agency inspections
• facilitate changes to Standard Operating Procedures, including writing and updating policies, processes, and procedures
• manage record retention and storage
• maintain communication across departments and support staff training in software programs.

What we're looking for

Skills & competencies

quality systems specialist

quality assurance

blood bank of alaska

anchorage ak

occurrence investigations

internal audits

regulatory compliance

fda

aabb

standard operating procedures

record retention

blood banking

401(k) matching

paid time off

Work arrangement

• Weekend coverage required

Benefits & perks

• 401(k) and matching, dental, health and vision insurance, wellness resources, and paid time off.

Why this role

An associate’s or bachelor’s degree in a relevant field is strongly preferred, with experience potentially substituting through demonstrated regulatory interpretation and technical writing ability. At least one year in a highly regulated environment is preferred. Benefits include 401(k) and matching, dental, health and vision insurance, wellness resources, and paid time off.

About the employer

Blood Bank of Alaska, Inc. is hiring for this role. Industry: Blood and Organ Banks. Sector: 62.