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Blood Bank of Alaska · 2 months ago

Quality Systems and Software Specialist

Anchorage, AK

Full-time

Onsite

Mid Level

3+ years exp

Blood Bank of Alaska (BBA) is seeking a detail-oriented Quality Systems and Software Specialist at our main campus in Anchorage, AK. This role is responsible for promoting regulatory compliance, managing the occurrence program, and administering the Blood Establishment Computer System (BECS) and other software, while providing essential support for quality processes and assessments.

Health CareMedicalPharmaceutical

Responsibilities

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

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

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

Quality assuranceRegulatory complianceBlood Establishment Computer SystemSoftware trainingAuditingTechnical writingMicrosoft OfficeInterpersonal skillsProblem-solvingOrganizational skillsCommunication skills

Required

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

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

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

Minimum: Valid Driver's License