Full-Time QA Documentation Specialist

Department: Research & Development

Reports to: Senior Director, Quality

Location: Remote Work, US only

Position Summary: The QA Documentation Specialist will be responsible for managing, reviewing, and maintaining quality system documentation and supporting documentation in compliance with regulatory standards and organizational policies. This role will play a key part in ensuring document accuracy, control, and accessibility within Sabin’s Quality Management System (QMS), with a strong focus on implementing and utilizing MasterControl for document lifecycle management.

Key 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.
• Participate in the implementation, administration and oversight of the training module in MasterControl.
• 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.
• 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.

Preferences:

• 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.
• Familiarity with Box and ZenQMS and other eDMS platforms.
• Previous oversight of eQMS controlled document systems supporting audits or regulatory inspections.

Core Competencies:

• Attention to detail and accuracy.
• Strong problem-solving and critical-thinking skills.
• Ability to work independently and collaboratively in a cross-functional team.
• Adaptability and willingness to support evolving Sabin’s QMS needs.

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