Quality Document Management Specialist I

Company Information

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Company Culture

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

Job Overview Summary

The Document Management Specialist I supports the Quality Assurance/Compliance Department by administering and maintaining controlled documentation within Advarra’s Quality Management System (QMS). This role ensures documentation integrity, regulatory compliance, and inspection readiness by supporting document lifecycle management, audit activities, and quality system processes. The role collaborates within QA/Compliance and across the organization to support effective quality and training systems.

Job Duties & Responsibilities

• Document Control & QMS (Quality Management System) Support: Responsible for the management of controlled documents (policies, procedures, work instructions, reports, and records) within the QMS. Maintain documents throughout their lifecycle, including creation, review, approval, revision, version control, archival, and retirement. Ensure documentation complies with Good Documentation Practices (GDocP).
• Electronic Document Management System (EDMS) Administration: Maintenance of user accounts, roles, permissions, workflows, document categories, review cycles, and retention rules.
• Audit & Inspection Support: Assist with retrieval of controlled documents in support of customer audits, inspections, and assessments. Support tracking and coordination of customer assessment requests.
• Training & Communication: Communicate training and document review requirements to quality system users. Support the Training and Compliance teams to ensure alignment between the EDMS and the training matrix.
• Quality Events & Continuous Improvement: Administration of nonconformance reports (Quality Incident Reports (QIRs) and CAPAs). Identify issues, recommend process improvements, and contribute to quality system enhancements.
• Make decisions within established guidelines and procedures.
• Perform other duties as assigned.

Location

This role is open to candidates working remotely in United States and Canada. Availability during standard U.S. business hours is required (Eastern time zone preferred)

Basic Qualifications

• Bachelor’s degree or equivalent experience
• 2–4 years of relevant experience in document control, quality systems, or regulated operations.
• Excellent organizational skills, managing priorities, deadlines, and workload.
• Demonstrate attention to detail, accuracy, and thoroughness.
• Effectively and professionally communicate with all levels of staff.
• Proficiency with Microsoft Office tools (Word, Excel, SharePoint/OneDrive).
• Ability to identify and resolve problems.
• Ability to work independently; effectively balance team and individual responsibilities.

Preferred Qualifications

• Experience managing controlled documents, especially within a Quality Management System (QMS) in an FDA (or similar) regulated business.
• Experience, training, or certifications in Quality Assurance.
• Knowledge of Federal regulations for human research (21 CFR 50, 56, 312 and 812; and 45 CFR 46)
• Experience with electronic Quality Management Systems (eQMS) or EDMS platforms (e.g., ZenQMS, Veeva, MasterControl, or SharePoint-based systems).
• Familiarity with GxP, ISO 9001, or ISO 13485 quality systems

Physical and Mental Requirements

• Sit or stand for extended periods of time at stationary workstation
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Learn and comprehend basic instructions
• Focus and attention to tasks and responsibilities
• Verbal communication; listening and understanding, responding, and speaking

Advarra is an equal opportunity employer that is committed to providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability, genetic information, or any other status or characteristic protected by federal, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.

The base salary range for this role is $64,344 - $106,168. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.