Quality Systems Specialist

Blood Bank of Alaska, Inc.•Anchorage, AK

15d•Onsite

About The Position

Blood Bank of Alaska (BBA) is seeking a detail-oriented Quality Systems Technical Writer 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. This position will be responsible for: Promoting organizational compliance with accrediting agency, state and federal regulations Managing BBA's occurrence programs Perform investigations for occurrences Manage and perform internal audits Facilitate changes to BBA's Standard Operating Procedures (SOPs) This role has a heavy focus reviewing procedural deviations and performing internal assessments. Excellent analysis, critical thinking, and written communications skills are required. Knowledge of blood banking, pharmaceutical manufacturing, or healthcare is certainly a plus.

Requirements

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 one year 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

Nice To Haves

Knowledge of blood banking, pharmaceutical manufacturing, or healthcare is certainly a plus.

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 Deviations 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 queries, 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.
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.