[Remote] QA Documentation Specialist

Note: The job is a remote job and is open to candidates in USA. Sabin Vaccine Institute is dedicated to improving vaccine accessibility and innovation. The QA Documentation Specialist will manage and maintain quality system documentation ensuring compliance with regulatory standards and organizational policies. 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 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 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. Skills • 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. • 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 MasterControl (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 and 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 Overview • A non-profit organization that promotes advances in vaccine development, delivery and distribution focusing on polio, rubella, rotavirus. It was founded in 1996, and is headquartered in Washington, District of Columbia, USA, with a workforce of 51-200 employees. Its website is Apply tot his job