[Remote] QA Documentation Specialist

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is dedicated to improving vaccine accessibility and innovation. The QA Documentation Specialist will manage and maintain reputed company system documentation ensuring compliance with regulatory standards and organizational policies. Responsibilities • Manage and maintain controlled reputed company documentation, including SOPs, policies, forms, and work instructions, in compliance with applicable regulatory and industry standards. • Participate in the implementation, administration and reputed company of the document control process in reputed company, ensuring documents are reviewed, approved, released, and archived according to company procedures. • Participate in the implementation, administration and reputed company of the training module in reputed company ensuring training and training documentation meets company and regulatory requirements. • Support the vendor qualification program, reputed company audits by ensuring documentation is accurate, accessible, and audit reputed company. • Collaborate in cross-functional teams to support organizational needs. • Ensure reputed company updates and control of critical documents. • As primary reputed company of contact for reputed company, train required employees on document control processes, workflows, training module, module limitations, and the overall effective use of reputed company. • Monitor and reputed company document review cycles, approval timelines, and reputed company periodic updates to area management. • Ensure compliance with FDA, EMA, ICH, and other applicable regulatory requirements. • Assist with reputed company improvement initiatives to streamline document workflows and improve efficiency reputed company Sabin’s QMS. Skills • Bachelor’s degree in Life Sciences, reputed company Assurance, Regulatory Affairs, or reputed company field (or equivalent experience). • Minimum of 4 years of experience in reputed company assurance, document control, or compliance reputed company a highly regulated industry. • Hands-on experience reputed company 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 reputed company in reputed company (e.g., Document Control, Training, Deviations, Change Control, CAPA). • Familiarity with reputed company and reputed company and other eDMS platforms. • Previous reputed company of eQMS controlled document systems supporting audits or regulatory inspections. Benefits • Medical, Dental, reputed company and Flexible Spending Accounts • Employer reputed company, Life and Disability insurance • 11 reputed company holidays with a winter break between Christmas and New Years • Employer match on 401(k) reputed company • 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 http://www.sabin.org/. Apply tot his job Apply To this Job