Specialist Facilities Quality & Regulatory Documentation

Overview

Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary

Under the direction of Facilities Management, provides technical writing, quality-system, and regulatory-documentation support for Facilities. Develops, revises, organizes, routes, maintains, and supports implementation of controlled documentation necessary to communicate technical and operational requirements and maintain Versiti compliance. Works collaboratively with Facilities Management, Quality, subject-matter experts, and operational stakeholders to understand technical and business processes and translate them into clear, accurate, usable documentation. Supports controlled procedures, work instructions, forms, records, training and validation documentation, eQMS workflows, audit readiness, and documentation associated with Facilities systems, maintenance, monitoring, infrastructure, and regulated environments. The position serves as a documentation specialist for Facilities and provides coordination and structure to ensure documentation is complete, standardized, appropriately controlled, and implemented in accordance with organizational and regulatory requirements. The position is responsible for the quality, organization, clarity, control, and coordination of Facilities documentation, while technical and operational subject-matter experts remain responsible for the accuracy and approval of the underlying technical requirements.

Total Rewards Package

CompensationThe target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications.BenefitsVersiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

Responsibilities

• Technical Writing and Documentation Development: Create and revise Facilities documents, SOPs, and other controlled documents, this includes translating complex technical, operational, maintenance, and compliance information into clear, accurate, user-friendly documentation.
• Document Control & eQMS Coordination: Coordinate document lifecycle activities, including creation, revision, approval, implementation, and version control while partnering with Quality professionals and document owners to ensure quality and compliance.
• Quality, Regulatory & Audit Documentation: Supports activities related to audits, deviations, change controls, and validation. Reviews documentation for consistency and compliance.
• Facilities Systems & Project Documentation: Develops and maintains documentation supporting maintenance programs, critical equipment, building systems, environmental monitoring, infrastructure projects, and regulated operations.
• Training & Change Implementation Support: Creates and updates training and implementation materials for new or revised procedures and controlled processes. Coordinates document readiness, effective dates, stakeholder communications, and training requirements for change implementation.
• Standardization, Improvement & General Support: Promotes consistency in Facilities documentation, terminology, and procedures across Versiti locations to support enterprise documentation standards. Identifies and implements improvements to documentation processes, control practices, and eQMS utilization to enhance efficiency and compliance.
• Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
• Understands and performs in accordance with all applicable regulatory and compliance requirements
• Complies with all standard operating policies and procedures

Qualifications

Education

• High School or equivalent required
• Bachelor's Degree With degree or coursework in technical communication, professional writing, English, quality systems, life sciences, engineering technology, or a related field. preferred

Experience

• 1-3 years Technical writer, documentation specialist, quality documentation specialist, document-control specialist, or in a position with significant responsibility for creating and revising technical or controlled documentation. required
• 1-3 years Developing procedures, work instructions, forms, training materials, or comparable technical documentation. required
• Less than 1 year Experience working within an electronic Quality Management System (eQMS), document-management system, or controlled-document environment. required
• Less than 1 year Experience using Information Mapping or similar tools or methodology for organizing technical information for an intended audience. preferred
• 1-3 years Experience working in a regulated environment such as cGMP, pharmaceutical, medical device, biologic, diagnostic testing, laboratory, healthcare, blood banking, or other quality-regulated operation. preferred
• Less than 1 year Experience supporting documentation associated with audits, inspections, CAPAs, deviations, investigations, change controls, or training preferred. preferred
• Less than 1 year Facilities, engineering, maintenance, laboratory, infrastructure, environmental monitoring, or building-systems documentation experience is beneficial but not required. preferred

Knowledge, Skills and Abilities

• Technical Writing and Communication: Strong technical writing, editing, grammar, verbal communication, and document design skills. required
• Process Analysis & Procedure Development: Ability to understand complex technical, operational, and business processes and translate them into clear, accurate procedures and work instructions. required
• Document Control & Quality Systems: Knowledge of document control principles, including review and approval workflows, revision management, version control, change management and other eQMS requirements. required
• Regulatory Compliance & Controlled Documentation: Understanding of regulated documentation practices and the ability to ensure compliance with organizational, quality, and regulatory requirements for audit readiness. required
• Attention to Detail & Document Accuracy: Ability to identify gaps, inconsistencies, conflicting requirements, and opportunities to improve clarity, compliance, and usability. required
• Subject Matter Expert (SME) Collaboration: Ability to effectively partner with SMEs, distinguish content ownership from documentation responsibilities, and facilitate document reviews and approvals. preferred
• Project Coordination & Prioritization: Ability to manage multiple documentation projects simultaneously, prioritize workload, track action items, and meet deadlines. preferred
• Problem Solving & Cross-Functional Collaboration: Strong analytical skills, independent judgment, adaptability, and the ability to work effectively across Facilities, Quality, operations, and project teams. preferred

Tools and Technology

• Working knowledge of applicable business, documentation, and quality-management tools, including: • Microsoft Word • Microsoft Excel • Microsoft PowerPoint • Microsoft Visio required
• Microsoft Project or equivalent project-management tools preferred
• Microsoft Teams and SharePoint required
• Electronic Quality Management Systems (eQMS), such as IQVIA or equivalent systems preferred
• Adobe Acrobat or equivalent PDF/document-management tools required
• Captivate or other training-content development tools, as applicable preferred
• Ability to learn additional Facilities, quality, maintenance, monitoring, or business systems as required. preferred

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