Quality Systems Specialist: Regulatory & Audit Lead

Blood Bank of Alaska Inc; Anchorage (AK); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Dental insurance

Health insurance

Vision insurance

Wellness resources

Paid time off

Job summary

Blood Bank of Alaska is seeking a detail-oriented Quality Systems Specialist to support the Quality Assurance team at the Anchorage campus. This full-time role focuses on maintaining compliance with accrediting agencies and regulatory requirements, overseeing investigations, audits, and SOP updates.

The position requires excellent organizational and communication skills, proficiency in MS Office, and the ability to work independently in a fast-paced, regulated environment.

Qualifications

• Knowledge of general safety and quality assurance policies.
• Proficient in Microsoft Office; strong written and verbal communication.
• Experience in a regulated environment is preferred.

Responsibilities

• Promote compliance with accrediting bodies, state and federal regulations.
• Manage occurrence programs and perform investigations for occurrences.
• Manage and perform internal audits and write audit reports.
• Facilitate SOP changes and update related policies.
• Assist with FDA submissions and inspections as needed.

Skills

Strong organizational skills

Excellent communication

Microsoft Office proficiency

Attention to detail

Independent work ethic

Education

Associate's or Bachelor's in a relevant field

Job description

Blood Bank of Alaska is seeking a detail-oriented Quality Systems Specialist to support the Quality Assurance team at the Anchorage campus. This full-time role focuses on maintaining compliance with accrediting agencies and regulatory requirements, overseeing investigations, audits, and SOP updates.

The position requires excellent organizational and communication skills, proficiency in MS Office, and the ability to work independently in a fast-paced, regulated environment.