QA Documentation Specialist

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November 14

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Sabin Vaccine Institute

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Healthcare Insurance • Biotechnology • Non-profit

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

51 - 200 employees

Founded 1993

⚕️ Healthcare Insurance

🧬 Biotechnology

🤝 Non-profit

💰 $35M Grant on 2023-01

📋 Description

• 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 MasterControl, ensuring documents are reviewed, approved, released, and archived according to company procedures. • Participate in the implementation, administration, and oversight of the training module in MasterControl 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 the primary point of contact for MasterControl, train required employees on document control processes, workflows, training module, module limitations, and the overall effective use of MasterControl. • 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.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Quality Assurance, Regulatory Affairs, or related field (or equivalent experience) • Minimum of 4 years of experience in quality assurance, document control, or compliance within a highly regulated industry • Hands-on experience MasterControl 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.

🏖️ 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)