Technical Writer

Job Description

Blood Bank of Alaska, Inc. is seeking a detail-oriented Technical Writer & Quality Systems Specialist to join our Quality Assurance team. As a key member of our team, you will provide essential support for quality processes and assessments.

Key Responsibilities

• Promote organizational compliance with accrediting agency, state and federal regulations.
• Write, revise, edit, and approve Standard Operating Procedures (SOPs).
• Assist document owners in writing and revising SOPs.
• Manage BBA's document control process.
• Ensure consistency across departments when policies or procedures change.
• Perform investigations for occurrences.
• Perform internal audits.

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 include blood center processes, procedures, work areas, electronic queries, and documents.
• Provide support during external agency inspections (FDA, AABB, etc.).
• Manage record retention process and record storage areas.
• Facilitate changes to Standard Operating Procedures (SOPs). This may include writing and updating policies, processes, and procedures.
• Use software to prepare and edit SOPs, attachments, and forms, ensuring:
  • Use of proper punctuation, grammar, spelling, and style.
  • Consistency of abbreviations, format, and terminology.
  • Clarity of content and incorporation of all required material.
• Assist document owners and management who write and revise SOPs.
• Conduct research for creation of and changes to SOPs, utilizing manuals, periodicals, AABB standards, FDA regulations, and relevant sources.
• Coordinate document control process with the Document Control Specialist.
• Maintain positive communication with all departments. Promote a positive work environment in which staff work cooperatively towards objectives.
• Exhibit support of BBA 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

• Maintain a high standard for conscientious, courteous, and enthusiastic service to internal and external customers, and the public in general.
• Maintain a high level of problem-solving skills.

Qualification Requirements

• Highly detailed orientated.
• Strong computer skills, Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to work independently, self-motivating, perform tasks of a detailed nature accurately within required timeframes, and adapt to fluctuating workloads.
• Exceptional organizational skills and ability to prioritize work.
• Thorough knowledge of business English, spelling, and punctuation. Effective written and verbal communication skills. Excellent writing ability for technical, professional, and other related documents.
• Ability to demonstrate strong technical writing skills given initial information pertaining to subject matter and identify changes needed in documents and promote implementation of changes effectively in a timely manner.
• Ability to problem solve at a high level through interpretation of regulatory guidelines, applicable laws and statures, industry standards, and quality-focused decision making.
• Demonstrate 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 instruct and train document owners and authors on writing and updating documents in Q-Pulse.
• Ability to instruct and train copyholders on preparing staff reading lists and maintaining SOP manuals.
• Ability to instruct and train staff in additional Q-Pulse modules.
• Ability to organize and maintain company records.
• Ability to interface effectively and harmoniously with employees, public, and regulatory inspectors.
• Knowledge of general safety and quality assurance procedures.
• Ability to maintain confidentiality of donors, customers, employees, and BBA business information.
• Ability to work in an ever changing environment.

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 two or three years of journalism or technical writing.

Certificates, Licenses, Etc.

• Minimum: Valid Drivers License.

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.

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