Quality Systems and Software Specialist

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Benefits :

401(k)

401(k) matching

Dental insurance

Health insurance

Vision insurance

Wellness resources

Blood Bank of Alaska Position Description

Position Title : Quality Systems and Software Specialist

Department : Quality Assurance

Reports To : Director of Quality Assurance

Date Updated : November 2025

Position(s) Supervised : None

POSITION SUMMARY

Blood Bank of Alaska (BBA) is seeking a detail-oriented Quality Systems and Software Specialist at our main campus in Anchorage, AK. For this full-time position, you will be a key member of the Quality Assurance team, providing the blood bank with essential support for quality processes and assessments. The Quality Systems and Software Specialist at the Blood Bank of Alaska (BBA) is responsible for promoting regulatory compliance, managing the occurrence program, and administering the Blood Establishment Computer System (BECS) and other software. Key duties include conducting investigations, performing audits, supporting external inspections, managing procedures and records, and providing software training.

This position will be responsible for :

• Promote organizational compliance with accrediting agency, state, and federal regulations
• Manage BBA's occurrence program
• Perform investigations for occurrences
• Manage and perform internal audits
• Facilitate changes to BBA's Standard Operating Procedures (SOPs)
• Administrate BBA's Blood Establishment Computer System (BECS) and any other applicable software program
• Provide customer service to BBA's software users
• Manage and perform software upgrades and validations

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform duties in compliance with all applicable regulatory and accrediting agencies. Ensure OSHA regulations

and cGMPs are adhered to.

• Perform occurrence investigations including Occurrence Reports (ORs), Post Donation Information (PDI),

Biological Product Deviation Reports (BPDRs), and Quarantine and Lookback (Q&LB) for positive test results.

• Assist with the review, compilation, and submission of FDA reports, correspondence, product licensing, etc.
• Develop operational audit plans, perform audits, write audit reports, and issue audit findings to department

management. Audits will include : blood center processes, procedures, work areas, electronic records, and

documents.

• Provide support during external agency inspections (FDA, AABB, etc.).
• Facilitate changes to Standard Operating Procedures (SOPs). This may include writing and updating policies,

processes, and procedures.

• Manage record retention process and record storage areas.
• Administrate BBA's Blood Establishment Computer System (BECS) and other applicable software programs.
• Provide customer service to BBA's software users.
• Manage and perform software configuration changes, upgrades, and validations where applicable.
• Maintain positive communication with all departments. Promote a positive work environment in which staff work

cooperatively toward objectives.

• Exhibit support of BBA's values, mission statement, quality objectives, and customer service standards at all

times.

• Perform other duties as assigned and qualified to do.

CUSTOMER INTERACTION / PROBLEM SOLVING

• Must maintain a high standard for conscientious, courteous, and enthusiastic service to internal and external customers, and the public in general.
• Must make customer's needs a high priority in face-to-face, telephone, and email contact.
• Must consistently deliver service in a timely, accurate, professional, and friendly manner.
• Must demonstrate a high level of problem-solving skills.

QUALIFICATION REQUIREMENTS

To perform this job successfully, each essential duty (as listed above) must be performed satisfactorily. The requirements listed below are representative of the knowledge, skill, and ability required.

GENERAL KNOWLEDGE, SKILLS, AND ABILITIES

• Knowledge of general safety and quality assurance policies.
• Exceptional computer skills. Proficient in Microsoft Office applications (Word, Excel, Access).
• Strong organizational skills and ability to prioritize tasks.
• Strong interpersonal and communication skills.
• Effective written and verbal communication skills.
• Ability to work independently, be self-motivating, perform tasks of a highly detailed nature accurately within

required timeframes, and adapt to fluctuating workloads.

• Ability to write and interpret technical, professional, and other work-related documents.
• Ability to problem solve at a high level through interpretation of regulatory guidelines, applicable laws and

statutes, and industry standards, and using quality-focused decision making.

• Ability to network with internal and external resources, build relationships conducive to a quality environment and

continue growth in knowledge areas related to industry.

• Ability to interface effectively and harmoniously with co-workers, the general public, and regulatory inspectors.
• Ability to perform job duties in a manner that is professional, ethical, diplomatic, inquisitive, and flexible.
• Ability to instruct and train staff in software programs.
• Ability to organize and maintain company records.
• Ability to maintain confidentiality of donors, customers, employees, and BBA business information..

EDUCATION Associate's or Bachelor's Degree in relevant field strongly preferred (English, journalism, etc.). Experience may be substituted with a demonstrated ability to perform regulatory interpretation and advanced technical writing.

EXPERIENCE Minimum three years in highly regulated environment preferred which included responsibility for compliance, policy,

and procedure development and implementation while working with a diverse employee population.

CERTIFICATES, LICENSES, ETC

Minimum : Valid Driver's License

Preferred : MLT, MT, MLS, or SBB (ASCP). American Society of Quality (ASQ) CQA.

WORK ENVIRONMENT

• Extensive use of computers.
• Must be able to lift at least 30 pounds and sit for long periods of time.
• Potential hazard due to exposure to blood or other potentially infectious materials. The Blood Bank of Alaska follows OSHA Bloodborne Pathogens Standards in the workplace.
• Must be able to walk moderate distances, climb stairs, reach, push, pull, and bend in order to perform his / her job duties.

Blood Bank of Alaska is a family of over one hundred dedicated staff from various backgrounds and expertise. Our focus on innovation and donor satisfaction is at the core of everything we do.

Blood Bank of Alaska is more than just a blood center. It is home to a talented team of professionals. BBA strives to provide benefits beyond a salary because our employees are essential to our success.

For more than 60 years, Blood Bank of Alaska has been at the forefront of Alaska healthcare ensuring that medical facilities across the state have a safe and adequate blood supply. More than 2,000 volunteer blood donors visit a BBA blood center every month in order to supply blood in case of accidents, trauma, heart surgery and treatment of diseases such as cancer. Blood Bank of Alaska collected 682 units the first year of operation in 1962 and we now collect over 20,000 units a year and ship those units thousands of miles throughout the state from Barrow to Juneau.

Benefits

Health Insurance

Each year, you have the opportunity to choose the health and insurance benefits that are right for you and your family. You have choices in these areas :

• Medical
• Dental
• Vision
• Life Insurance
• Disability Insurance
• Health Savings Account

Wellness

Your health matters to us. BBA provides a comprehensive wellness program that will help you improve your health, achieve your individual goals, and make wellness a part of everyday life for you and your family.

Retirement

Blood Bank of Alaska provides retirement benefits designed to help you achieve your future retirement goals :

• 401(k) plan : a savings plan with matching contributions from BBA

Work / Life Benefits

We believe that work is important, but balance is essential. BBA provides several programs designed to help achieve this balance for our team members :

• Paid Annual Leave
• Educational Assistance
• Employee Assistance Programs
• Service Awards
• Employee Discounts on Cell Phones (Other Items As Available)

BBA is an equal opportunity employer. Qualified applicants are considered for employment without regard to race, color, religion, national origin, age, disability, marital / veteran status or any other legally protected status. Those individuals seeking assistance in the recruitment process are strongly encouraged to contact our Human Resource Department.