QA Documentation Specialist

Job 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) Apply tot his job Apply To this Job