Quality Systems and Software Specialist

Benefits

• 401(k) matching
• Dental insurance
• Health insurance
• Vision insurance
• Wellness resources

Qualifications

• 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-motivated, 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
• Experience may be substituted with a demonstrated ability to perform regulatory interpretation and advanced technical writing

Experience

• Minimum one year experience with healthcare or quality system related software applications
• One year of experience in highly regulated environment preferred which included responsibility for compliance, policy, and procedure development and implementation while working with a diverse employee population

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
• Must be able to walk moderate distances, climb stairs, reach, push, pull, and bend in order to perform his/her job duties

Benefits

• Health Insurance
• 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

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

Work/Life Benefits

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

About the Role

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.

Responsibilities

• Administrate BBA’s Blood Establishment Computer System (BECS) and other applicable software programs
• Support software changes or implement new software needed for changes to equipment or processes
• Manage and perform software configuration changes, upgrades, and validations where applicable
• Build and optimize software programs to support BBA operations and improvements
• Using vendor supplied documentation, in tandem with vendor SMEs, troubleshoot software problems
• Work with vendor to implement new software upgrades. Evaluate release notes to determine impact of upgrade
• Request feature enhancements to improve software
• Provide customer service to BBA’s software users
• 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
• 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

Skills

• 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-motivated, 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.

Skills

• Ability to work independently, be self-motivated, 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.