Sabin Vaccine Institute · 21 hours ago
Quality Assurance Documentation Specialist
United States
Full-time
Remote
Mid Level
$72K/yr - $85K/yr
4+ years expSabin Vaccine Institute is dedicated to making vaccines more accessible and improving lives through immunization. The Quality Assurance Documentation Specialist will manage, review, and maintain quality system documentation to ensure compliance with regulatory standards and organizational policies, focusing on document accuracy and control within the Quality Management System.
AssociationBiopharmaNon Profit
Responsibilities
Manage and maintain controlled quality documentation, including SOPs, policies, forms, and work instructions, in compliance with applicable regulatory and industry standards
Participate in the implementation, administration and oversight of the document control process in Master Control, ensuring documents are reviewed, approved, released, and archived according to company procedures
Participate in the implementation, administration and oversight of the training module in Master Control ensuring training and training documentation meets company and regulatory requirements
Support the vendor qualification program, internal and external audits by ensuring documentation is accurate, accessible, and audit ready
Collaborate in cross-functional teams to support organizational needs
Ensure timely updates and control of critical documents
As primary point of contact for Master Control, train required employees on document control processes, workflows, training modules, module limitations and the overall effective use of Master Control
Monitor and track document review cycles, approval timelines, and provide periodic updates to area management
Ensure compliance with FDA, EMA, ICH, and other applicable regulatory requirements
Assist with continuous improvement initiatives to streamline document workflows and improve efficiency within Sabin’s QMS
Qualification
Required
Bachelor's degree in Life Sciences, Quality Assurance, Regulatory Affairs, Computer Science, or a related field preferred
Candidates with relevant experience in quality assurance, document control, or regulated environments will be considered in lieu of a formal degree
Minimum of 4 years of experience in quality assurance, document control, or compliance within a highly regulated industry
Hands-on experience Master Control or similar electronic document management systems (EDMS)
Strong knowledge of document control best practices and regulatory requirements (FDA 21 CFR Part 11, GxP, ISO standards)
Excellent organizational, written, and verbal communication skills
Ability to manage multiple priorities while maintaining attention to detail
Preferred
Exposure or Experience in the pharmaceutical, vaccine, or biotechnology industries, cGMP and required regulatory compliance
Experience implementing, training and administration of QMS modules within in Master Control (e.g., Document Control, Training, Deviations, Change Control, CAPA)
Familiarity with Box and ZenQMS and other eDMS platforms
Previous oversight of eQMS controlled document systems supporting audits or regulatory inspections
Benefits
Medical
Dental
Vision
Flexible Spending Accounts
Employer paid, Life and Disability insurance
11 paid holidays with a winter break between Christmas and New Years
Employer match on 401(k)
Company
Sabin Vaccine Institute
A non-profit organization that promotes advances in vaccine development, delivery and distribution focusing on polio, rubella, rotavirus.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$63.1MKey Investors
Biomedical Advanced Research and Development Authority (BARDA)Coalition for Epidemic Preparedness Innovations
2023-01-12Grant· $35M
2022-09-13Grant· $21.8M
2022-05-17Grant· $6.3M
Leadership Team
Amy Finan
Chief Executive Officer
Rebecca Martin
President for Global Immunization
Recent News
Sabin Vaccine Institute
2025-12-04
Global Virus Network
2025-11-27
Sabin Vaccine Institute
2025-07-22
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